Effectiveness of Acupuncture and Doxylamine/Pyridoxine for Moderate to Severe Nausea and Vomiting in Pregnancy

March 31, 2022 updated by: Xiaoke Wu

Effectiveness of Acupuncture and Doxylamine/Pyridoxine for Moderate to Severe Nausea and Vomiting in Pregnancy: A Randomized Controlled Two-by-two Factorial Trial

Nausea and vomiting in pregnancy (NVP) is one of the most common symptoms of pregnancy affecting 50-85% of women during the first half of pregnancy. Maternal morbidity is common and includes psychological effects, financial burden, clinical complications from nutritional deficiencies, gastrointestinal trauma, and in rare cases, neurological damage. As the main means of alternative treatment, economical and easy to obtain; the clinical efficacy of acupuncture treatment of this disease has low level of evidence and needs to be reconfirmed. Doxylamine vitamin B6 sustained release tablets (Diclectin, combination of doxylamine succinate (10mg) and pyridoxine hydrochloride (10mg) are The American College of Obstetricians and Gynecologists recommends with Level A evidence the use of vitamin B6 in combination with doxylamine as first-line pharmacotherapy for treatment of NVP. The efficacy and safety of Diclectin has been confirmed in many years of research, but there is no evidence of high-level evidence-based medicine for the Chinese population. The purpose of this multicenter, randomized, double-blind, placebo-controlled trial was to investigate the efficacy and safety of acupuncture versus Diclectin in the treatment of NVP. We hypothesis that: (1)Sham acupuncture and Diclectin (Arm B) is more effective than sham acupuncture and placebo (Arm D); (2)Active acupuncture and placebo (Arm C) is more effective than sham acupuncture and placebo (Arm D); (3) There is no interaction (either synergistic or antagonistic effects) between the two interventions of active acupuncture and Diclectin in patients with NVP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects will be randomized into one of the four treatment arms: A) active acupuncture (30 min /every day) + Diclectin (combination of doxylamine succinate (10 mg) and pyridoxine hydrochloride (10 mg) , 2-4 tablets/day); B) sham acupuncture (30 min /every day) + Diclectin (2-4 tablets/day); C) active acupuncture (30 min / every day) + Diclectin placebo (2-4 tablets/day); D) sham acupuncture (30 min /every day) + Diclectin placebo (2-4 tablets/day). Participants will receive active acupuncture or sham acupuncture treatment daily, 14 times in total, and receive Diclectin or placebo treatment every day (2 tablets at bedtime for the first two days, if the symptoms are unrelieved, add one tablet in the morning, if the symptoms are still unrelieved, add another one tablet at three o 'clock in the afternoon) for 2 consecutive weeks, 28-56 tablets in total. Daily measurement PUQE score, Visual analog scale (VAS), Adverse events and concomitant medications. Weekly visits will include global assessment of well being, adverse events and concomitant medications. The visit after treatment will assess NVP quality of life (NVPQoL), SAS, SDS and so on. Participants will be followed up 30 days after treatment. Primary outcomes is difference of the mean change in PUQE score from baseline to the last visit. Secondary outcomes were some core outcome set for hyperemesis gravidarum, including weight difference, quality of life (change in Global assessment of well-being, NVPQOL, VAS, SDS and SAS), pregnancy complication, treatment compliance, neonatal outcomes; area under the curve of PUQE score, effect of intervention on PUQE score reduction over treatment period and adverse events.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
352

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Heilongjiang Provincial Hospital
      • Harbin, Heilongjiang, China
        • First Affiliated Hospital of Heilongjiang Chinese Medicine University
      • Hegang, Heilongjiang, China
        • Hegang Maternal and Child Health Hospital
      • Jiamusi, Heilongjiang, China
        • Affiliated Hospital of Jiamusi Medical University
      • Jiamusi, Heilongjiang, China
        • Jiamusi Maternal and Child Health Hospital
      • Jixi, Heilongjiang, China
        • Jixi Maternal and Child Health Hospital
      • Mudanjiang, Heilongjiang, China
        • Mudanjaing Maternal and Child Health Hospital
      • Shuangyashan, Heilongjiang, China
        • Shuangyashan Maternal and Child Health Hospital
    • Heilongjing
      • Suihua, Heilongjing, China
        • Suihua Maternal and Child Health Hospital
    • Henan
      • Luoyang, Henan, China
        • Luoyang Hospital of TCM
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Xuzhou Central Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Jiangxi Maternal and Child Health Hospital
    • Ningxia Hui Autonomous Region
      • Yinchuan, Ningxia Hui Autonomous Region, China
        • Ningxia Hui Autonomous Region Hospital of TCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women with 20-45 years of age;
  2. PUQE score ≥6;
  3. 7-14 weeks of gestation with viable fetus inside the uterine cavity confirmed by ultrasound dating;
  4. Less than 20% weight loss.

Exclusion Criteria:

  1. Having major medical problems such as malignant tumor, acute or subacute severe hepatitis, severe aplastic anemia, idiopathic thrombocytopenic purpura, acute appendicitis, acute pancreatitis, TORCH syndrome, etc
  2. Having chronic medical conditions such as poorly controlled diabetes, coronary heart disease, uncontrolled hypertension, etc
  3. Coexistence of other diseases that cause vomiting such as infectious disease, gestational trophoblastic disease, etc
  4. Having asthma, increased intraocular pressure, narrow-angle glaucoma, narrow peptic ulcer, pyloric obstruction, bladder neck obstruction, etc
  5. Taking antiemetics such as vitamin B6, ondansetron, metoclopramide, prednisone, anti-vomiting Chinese medicine, etc., within the past week
  6. Receiving conservative treatment such as dietary and lifestyle modification
  7. Abnormal physical examination and laboratory tests (minor abnormalities in laboratory tests due to pregnancy vomiting, such as liver function and ions, are acceptable for inclusion)
  8. Having mental handicaps or psychological disorders
  9. Allergic to doxylamine, other ethanolamine-derived antihistamines, pyridoxine hydrochloride, or any inactive ingredient in diclectin
  10. Using monoamine oxidase inhibitors
  11. Driving or operating heavy machinery
  12. Using alcohol or other central nervous system inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Diclectin plus active acupuncture
Diclectin (combination of doxylamine succinate (10 mg) and pyridoxine hydrochloride (10 mg) , 2-4 tablets/day) + active acupuncture (30 min /every day).
Drug: Diclectin
Diclectin (combination of 10 mg doxylamine and 10 mg pyridoxine hydrochloride in a delayed release tablet) During the first two days, patients will start with an initial oral dose of 2 tablets at bedtime. If the symptoms assessed on the second day are not relieved, 3 tablets will be administered on the third day (1 tablet in the morning and 2 tablets at bedtime). On the third day if the symptoms are still not relieved, another tablet will be added in the afternoon on the fourth day (1 tablet in the morning, 1 tablet in the afternoon and 2 tablets at bedtime). Therefore, the maximum assigned dosage of Diclectin or placebo tablets do not exceed 4 tablets per day. The treatment duration will lasts for 14 days.
Device: Active acupuncture
Participants will receive active acupuncture every day for 2 consecutive weeks, a total of 14 sessions. The needle will be left for 30 minutes. After de qi induced by acupuncture, the paired electrodes of the electroacupuncture device will be connected to the needle handle horizontally (except for PC6).
Other: Diclectin plus sham acupuncture
Diclectin (combination of doxylamine succinate (10 mg) and pyridoxine hydrochloride (10 mg), 2-4 tablets/day) + sham acupuncture (30 min /every day).
Drug: Diclectin
Diclectin (combination of 10 mg doxylamine and 10 mg pyridoxine hydrochloride in a delayed release tablet) During the first two days, patients will start with an initial oral dose of 2 tablets at bedtime. If the symptoms assessed on the second day are not relieved, 3 tablets will be administered on the third day (1 tablet in the morning and 2 tablets at bedtime). On the third day if the symptoms are still not relieved, another tablet will be added in the afternoon on the fourth day (1 tablet in the morning, 1 tablet in the afternoon and 2 tablets at bedtime). Therefore, the maximum assigned dosage of Diclectin or placebo tablets do not exceed 4 tablets per day. The treatment duration will lasts for 14 days.
Device: Sham acupuncture
Blunt-tipped placebo needles will be used. Participants will receive sham acupuncture every day for 2 consecutive weeks, a total of 14 sessions. The needle will be left for 30 minutes. After de qi induced by acupuncture, the paired electrodes of the electroacupuncture device will be connected to the needle handle horizontally (except for PC6). Then, the paired electrodes of the electroacupuncture device will be connected to the needle handle horizontally (except for PC6).
Other: Placebo plus active acupuncture
Diclectin placebo (2-4 tablets/day) + active acupuncture (30 min / every day)
Device: Active acupuncture
Participants will receive active acupuncture every day for 2 consecutive weeks, a total of 14 sessions. The needle will be left for 30 minutes. After de qi induced by acupuncture, the paired electrodes of the electroacupuncture device will be connected to the needle handle horizontally (except for PC6).
Drug: Diclectin placebo
Diclectin placebo will be packed and tested by a commercial pharmacy supply company specifically for this study. It have the same appearance, size, batch, odor, and taste compared with Diclectin. During the first two days, patients will start with an initial oral dose of 2 tablets at bedtime. If the symptoms assessed on the second day are not relieved, 3 tablets will be administered on the third day (1 tablet in the morning and 2 tablets at bedtime). On the third day if the symptoms are still not relieved, another tablet will be added in the afternoon on the fourth day (1 tablet in the morning, 1 tablet in the afternoon and 2 tablets at bedtime). Therefore, the maximum assigned dosage of placebo tablets do not exceed 4 tablets per day. The treatment duration will lasts for 14 days.
Other: Placebo plus sham acupuncture
Diclectin placebo (2-4 tablets/day) + sham acupuncture (30 min /every day)
Device: Sham acupuncture
Blunt-tipped placebo needles will be used. Participants will receive sham acupuncture every day for 2 consecutive weeks, a total of 14 sessions. The needle will be left for 30 minutes. After de qi induced by acupuncture, the paired electrodes of the electroacupuncture device will be connected to the needle handle horizontally (except for PC6). Then, the paired electrodes of the electroacupuncture device will be connected to the needle handle horizontally (except for PC6).
Drug: Diclectin placebo
Diclectin placebo will be packed and tested by a commercial pharmacy supply company specifically for this study. It have the same appearance, size, batch, odor, and taste compared with Diclectin. During the first two days, patients will start with an initial oral dose of 2 tablets at bedtime. If the symptoms assessed on the second day are not relieved, 3 tablets will be administered on the third day (1 tablet in the morning and 2 tablets at bedtime). On the third day if the symptoms are still not relieved, another tablet will be added in the afternoon on the fourth day (1 tablet in the morning, 1 tablet in the afternoon and 2 tablets at bedtime). Therefore, the maximum assigned dosage of placebo tablets do not exceed 4 tablets per day. The treatment duration will lasts for 14 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Score change of pregnancy unique quantification of emesis (PUQE) scale from baseline to day 15
Time Frame: Baseline to day 15; Scores ranged 3 to 15, with higher scores indicating more
Score change of pregnancy unique quantification of emesis (PUQE) scale from baseline to day 15
Baseline to day 15; Scores ranged 3 to 15, with higher scores indicating more

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Score change of maternal weight from baseline to the last visit
Time Frame: Baseline to day 15; no range of variation
Score change of maternal weight from baseline to the last visit
Baseline to day 15; no range of variation
Change of electrolyte index (sodium)
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: mmol/L
Baseline to day 15
Change of electrolyte index (potassium)
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: mmol/L
Baseline to day 15
Change of electrolyte index (calcium)
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: mmol/L
Baseline to day 15
Change of electrolyte index (chlorine)
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: mmol/L
Baseline to day 15
Change of electrolyte index (phosphorus)
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: mmol/L
Baseline to day 15
Change of electrolyte index (magnesium)
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: mmol/L
Baseline to day 15
Change of electrolyte index (iron)
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: μmol/L
Baseline to day 15
Change of electrolyte index (zinc)
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: μmol/L
Baseline to day 15
Change of AST
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: U/L
Baseline to day 15
Change of ALT
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: U/L
Baseline to day 15
Change of ALP
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: U/L
Baseline to day 15
Change of creatinine
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: μmol/L
Baseline to day 15
Change of urea
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: mmol/L
Baseline to day 15
Change of TSH
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: mIU/L
Baseline to day 15
Change of free triiodothyronine
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: pmol/L
Baseline to day 15
Change of free thyroxine
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: pmol/L
Baseline to day 15
Change of vitamin b1
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: ng/ml
Baseline to day 15
Change of vitamin b6
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: ng/ml
Baseline to day 15
Change of vitamin b12
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: ng/ml
Baseline to day 15
Change of cortisol
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: ug/dL
Baseline to day 15
Change of ghrelin
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: ng/ml
Baseline to day 15
Change of leptin
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: ng/ml
Baseline to day 15
Change of 5-hydroxytryptamine
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: ng/ml
Baseline to day 15
Change of substance P
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: pg/ml
Baseline to day 15
Change of arginine vasopressin plasma
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: pg/ml
Baseline to day 15
Change of GDF 15
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: pg/ml
Baseline to day 15
Change of IGFBP 7
Time Frame: Baseline to day 15
Value changes from baseline to last Visit. Unit: ng/ml
Baseline to day 15
Intravenous fluid treatment during treatment
Time Frame: Baseline to day 15
Intravenous fluid treatment during treatment
Baseline to day 15
Concomitant treatment
Time Frame: Baseline to day 15
Concomitant treatment
Baseline to day 15
Hospital admission during treatment
Time Frame: Baseline to day 15
Hospital admission during treatment
Baseline to day 15
Termination of pregnancy
Time Frame: Data collected from baseline to the end of follow-up period (four weeks after the end of treatment).
Termination of pregnancy. If the patient is suffering further aggravation of hyperemesis gravidarum, the termination of a wanted pregnancy will be done due to life in danger. Or congenital anomalies are found by ultrasound, the termination of a wanted pregnancy will be done.
Data collected from baseline to the end of follow-up period (four weeks after the end of treatment).
Maternal outcomes
Time Frame: Data collected from baseline to 42 days after postpartum.
Including pregnancy complications, termination of pregnancy and birth outcomes. Pregnancy complications including miscarriage (in the first trimester and in the second trimester), hypertensive disorders, and gestational diabetes; birth outcomes including live birth, vaginal delivery, cesarean section, gestational age, preterm, birth weight and small for gestational age.
Data collected from baseline to 42 days after postpartum.
Patient satisfaction with treatment
Time Frame: Baseline to day 15
Such as loss of confidence or intolerance to daily acupuncture and so on
Baseline to day 15
Treatment compliance
Time Frame: Baseline to day 15
Such as the percentage of drug or needle used; or drug tablets or acupuncture sessions.
Baseline to day 15
Offspring outcomes
Time Frame: Data collected from baseline to to 42 days after postpartum.
Including fetal and neonatal congenital anomalies, fetal and neonatal mortality, neonatal hypoglycemia and NICU admission.
Data collected from baseline to to 42 days after postpartum.
Area under the curve (AUC) of PUQE score over treatment
Time Frame: Baseline to day 15
Scores ranged 3 to 15, with higher scores indicating more severe NVP
Baseline to day 15
PUQE score reduction based on different TCM patterns
Time Frame: Scores ranged 3 to 15, with higher reduction indicating the better
PUQE score reduction based on different TCM patterns
Scores ranged 3 to 15, with higher reduction indicating the better
Adverse events and serious adverse events
Time Frame: Baseline to the end of follow-up (four weeks after the end of treatment)
The percentage of adverse events and serious adverse events
Baseline to the end of follow-up (four weeks after the end of treatment)
Quality of life: NVPQoL
Time Frame: Baseline to day 15
Range 30-210, high being poor QoL
Baseline to day 15
Quality of life: VAS
Time Frame: Baseline to day 15
Ranged 0-10, high being more severe symptoms
Baseline to day 15
Quality of life: SDS
Time Frame: Baseline to day 15
Range 25-10, high being more severe
Baseline to day 15
Quality of life: SAS
Time Frame: Baseline to day 15
Range 25-100, high being more severe
Baseline to day 15
Quality of life: global assessment of well-being
Time Frame: Baseline to day 15
Range 0-10, low being more severe
Baseline to day 15
PUQE score reduction at different levels of NVP
Time Frame: Scores ranged 3 to 15, with higher reduction indicating the better
PUQE score reduction at different levels of NVP
Scores ranged 3 to 15, with higher reduction indicating the better

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiaoke Wu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xuzhou Central Hospital
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Jiangxi Maternal and Child Health Hospital
Ningxia Hui Autonomous Region Hospital of TCM
Jixi Maternal and Child Health Hospital
Luoyang Hospital of TCM
Shuangyashan Maternal and Child Health Hospital
Heilongjiang provincial hospital
Jiamusi Maternal and Child Health Hospital
Hegang Maternal and Child Health Hospital
Suihua Maternal and Child Health Hospital
Mudanjaing Maternal and Child Health Hospital
Affiliated Hospital of Jiamusi Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Xiaoke Wu, Ph.D, First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NVPAct

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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