Diagnostic and Therapeutic Potential of Substance P/ NK1R Receptor in Primary Dysmenorrhea

February 20, 2025 updated by: Riffat Mehboob, Lahore Medical Research Center, LLP

Diagnostic and Therapeutic Potential of Substance P/ NK1R Receptor in Primary Dysmenorrhea: a Randomized Controlled Trial

Dysmenorrhea is characterized as excruciating menstrual cramps of uterine origin and is one of the most prevalent gynecological illnesses. Substance P (SP) and NK1R mediate the symptoms of various pain disorders with chronic and/or neuropathic pain. Objective: To evaluate diagnostic and therapeutic potential of Substance P/ NK1R receptor in primary dysmenorrhea. Study Design: This was a randomized controlled trial which took place at Lahore Medical Research Center from March 2024 to October 2024. Non-probability convenient sampling techniques was used for sampling. A total of 40 female participants was included in the study who met specific criteria for inclusion. The study comprised of three phases, Phase 1 (Before medication), Phase 2 (NSAIDs) and Phase 3(Dexamethasone + Aprepitant). 10 females with no dysmenorrhea participated as controls. The study duration spanned three menstrual cycles. 20 dysmenhorric and 6 controls were analyzed for NK1R levels. Several assessment tools were also used in the study,

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

This was a randomized controlled trial which took place at Lahore Medical Research Center from March 2024 to October 2024. Non-probability convenient sampling techniques was used for sampling. A total of 40 female participants was included in the study who met specific criteria for inclusion. 10 females with no dysmenorrhea participated as controls. The study duration spanned three menstrual cycles, during which participants were divided into three Phases. Phase 1: Blood samples of all 30 patients were collected prior to any medication. Phase 2: All 30 participants in this phase used NSAIDs (Non-steroidal Anti-Inflammatory Drugs), during their dysmenorrhea period. Phase 3: All the patients from phase 2 (n=30) received NK1R antagonist "Dexamethasone (6mg) + Aprepitant (80mg)" for 2 days. Out of these patients, 20 dysmenhorric and 6 controls were analyzed for NK1R levels.

Data Collection

A 5cc blood sample was collected from each participant on the 2nd day of their menstrual cycle before any intervention. Another 5cc blood sample was collected on the 2nd day of the menstrual cycle after the first intervention. Another 5cc blood sample was collected on the 2nd day of the menstrual cycle after the 2nd intervention. Prior to and following the intervention, a complete blood count (CBC) was conducted to assess any changes in blood parameters. Serum was extracted from the collected blood samples for further analysis.

Human SP and Neurokinin-1 Receptor (NK1R) levels measurement Human SP and its antagonist NK1R levels were analyzed using ELISA technique. This analysis was performed thrice to investigate the role of Substance P and NK1R in menstrual pain before and after the intervention. BT Lab Human Substance P and NK1R ELISA kit was used to measure levels of SP and NK1R in serum samples of participants (Catalogue Numbers: E1528Hu, E6938Hu).

Assessment tools

The study's participants filled out a basic questionnaire meant to collect sociodemographic information and analyze a variety of parameters. Body Mass Index (BMI), Family History of Pain, Age at Menarche, Length of Menstrual Cycle, Age of Onset of Dysmenorrhea, and Sleep Duration were all included in these surveys. The Depression Anxiety Stress Scale (DASS), Visual Analogue Scale (VAS), Mini Nutritional Assessment (MNA), International Physical Activity Questionnaire (IPAQ), and Pictorial Blood Loss Assessment Chart were among the other questionnaires used.

Visual Analogue Scale (VAS)

Female participants' levels of pain were measured using the Visual Analog Scale (VAS). With a scale from 0 to 10, where 10 is the most excruciating pain possible, the VAS is a well-known measure for assessing pain perception. Participants were divided into three groups to reflect varied levels of pain severity based on their VAS ratings obtained throughout the first three consecutive days of both menstrual cycles: Mild Pain, Moderate Pain, and Severe Pain.

Mini Nutritional Assessment (MNA)

The female participants' eating patterns were assessed using the Nestle Nutrition Institute Mini Nutritional Assessment in order to look into any possible associations between their diet and menstrual discomfort. Participants who scored between 24 and 30 had good nutritional status, those who scored from 17 to 23.5 were at risk of malnutrition, and those who scored under 17 were poorly nourished.

Depression Anxiety Stress Scale (DASS-21)

The DASS-21 was used to evaluate the psychological health of our subjects and comprehend how it related to dysmenorrhea. Based on their stated levels of stress, anxiety, and depression, participants were divided into five groups using this scale: normal, mild, moderate, severe, and extremely severe. A score of 0 to 9 indicates normal, 10 to 13 indicates mild depression, 14 to 20 indicates moderate depression, 21 to 27 indicates severe depression, and 28 or above indicates extremely severe depression. Scores between 0 and 7 indicate normal anxiety, 8 to 9 indicate mild anxiety, 10 to 14 indicate moderate anxiety, 15 to 19 indicate severe anxiety, and 20 or more indicate extremely severe anxiety. For stress, 0-14 represents normal, 15-18 represents mild, 19-25 represents moderate, 26-33 represents severe, and 34+ represents really severe stress.

Pictorial Blood Loss Assessment Chart (PBAC)

The Pictorial Blood Loss Assessment Chart (PBAC), a self-administered pictorial assessment chart that assigns scores based on how much tampons and cotton-based sanitary pads stain throughout a menstrual cycle, was given to the patients as a tool to measure their menstrual blood volume [24-26]. Reliability of the PBAC has been shown [25, 26]. They were given guidelines by the researcher on how to utilize the PBAC. Hypomenorrhea was linked to PBAC scores of 10 or less, regular monthly flow was linked to PBAC scores of 10 to 99, and heavy menstrual bleeding was linked to PBAC scores of 100 or more for two months. Cotton pads were the only sanitary goods used. Software for statistical analysis was used to determine scores.

Statistical Analysis

Data analysis was carried out using Graph Pad Prism 8.0.2, a statistical software package. The collected data, including questionnaire responses, CBC results, Substance P and NK1R levels, were analyzed to assess the effects of the interventions on menstrual pain and related factors. Two-way ANOVA test was used for analysis. P-value less than 0.05 was considered significant.

Ethical considerations

This study was approved by Ethical Review Board of Lahore Medical Research Center. The research followed declaration of Helsinki and written and informed consent was taken from all participants.

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.
40

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

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Prof. Dr. Riffat Mehboob

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The participants must be unmarried women of reproductive age who have moderate to severe dysmenorrhea.

  • The participants must experience dysmenorrhea during most menstrual cycles to be included in the study.
  • For controls, they must not have dysmenorrhea.

Exclusion Criteria:

Those with irregular or infrequent menstrual cycles.

  • Women who are taking oral contraceptive pills (OCPs) and using an intrauterine contraceptive device (IUD) excluded from the study.
  • Women who have reached menopause or have undergone a surgical procedure resulting in the cessation of menstruation excluded from the study.
  • Women who are pregnant or breastfeeding.
  • Women who taking any medication like sedatives and NSAIDs.
  • Women with PCOs, hysterectomy and uterine carcinoma will not be included.

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: Sequential Assignment
  • Masking: None (Open Label)

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.
No Intervention: Control Group
10 females with no dysmenorrhea participated as controls.
Experimental: NSAIDs and Aprepitant group (Sequential)
All 30 participants in this group used NSAIDs (Non-steroidal Anti-Inflammatory Drugs), during their dysmenorrhea period. Same patients from phase 2 (n=30) in next cycle received NK1R antagonist "Dexamethasone (6mg) + Aprepitant (80mg)" for 2 days.
Drug: Ibuprofen and Aprepitant
All 30 participants in this group used NSAIDs (Non-steroidal Anti-Inflammatory Drugs), during their dysmenorrhea period. Same patients from phase 2 (n=30) in next cycle received NK1R antagonist "Dexamethasone (6mg) + Aprepitant (80mg)" for 2 days.
Other Names:
  • NSAIDs, Neurokinin 1 Receptor antagonist

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
Visual Analogue Scale Score (Pain scale)
Time Frame: At the end of one cycle (each cycle is of 28-3- days)
Female participants' levels of pain were measured using the Visual Analog Scale (VAS). With a scale from 0 to 10, where 10 is the most excruciating pain possible, the VAS is a well-known measure for assessing pain perception. Participants were divided into three groups to reflect varied levels of pain severity based on their VAS ratings obtained throughout the first three consecutive days of both menstrual cycles: Mild Pain, Moderate Pain, and Severe Pain
At the end of one cycle (each cycle is of 28-3- days)
Mini Nutritional Assessment (MNA) Score
Time Frame: At the end of one cycle (each cycle is of 28-3- days)
The female participants' eating patterns were assessed using the Nestle Nutrition Institute Mini Nutritional Assessment in order to look into any possible associations between their diet and menstrual discomfort. Participants who scored between 24 and 30 had good nutritional status, those who scored from 17 to 23.5 were at risk of malnutrition, and those who scored under 17 were poorly nourished.
At the end of one cycle (each cycle is of 28-3- days)
DASS-21 (Depression Anxiety Stress Scale)
Time Frame: At the end of one cycle (each cycle is of 28-3- days)
The DASS-21 was used to evaluate the psychological health of our subjects and comprehend how it related to dysmenorrhea. Based on their stated levels of stress, anxiety, and depression, participants were divided into five groups using this scale: normal, mild, moderate, severe, and extremely severe. A score of 0 to 9 indicates normal, 10 to 13 indicates mild depression, 14 to 20 indicates moderate depression, 21 to 27 indicates severe depression, and 28 or above indicates extremely severe depression. Scores between 0 and 7 indicate normal anxiety, 8 to 9 indicate mild anxiety, 10 to 14 indicate moderate anxiety, 15 to 19 indicate severe anxiety, and 20 or more indicate extremely severe anxiety. For stress, 0-14 represents normal, 15-18 represents mild, 19-25 represents moderate, 26-33 represents severe, and 34+ represents really severe stress.
At the end of one cycle (each cycle is of 28-3- days)
Pictorial Blood Loss Assessment Chart (PBAC)
Time Frame: At the end of one cycle (each cycle is of 28-3- days)
The Pictorial Blood Loss Assessment Chart (PBAC), a self-administered pictorial assessment chart that assigns scores based on how much tampons and cotton-based sanitary pads stain throughout a menstrual cycle, was given to the patients as a tool to measure their menstrual blood volume. Reliability of the PBAC has been shown. They were given guidelines by the researcher on how to utilize the PBAC. Hypomenorrhea was linked to PBAC scores of 10 or less, regular monthly flow was linked to PBAC scores of 10 to 99, and heavy menstrual bleeding was linked to PBAC scores of 100 or more for two months. Cotton pads were the only sanitary goods used. Software for statistical analysis was used to determine scores.
At the end of one cycle (each cycle is of 28-3- days)

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.
Lahore Medical Research Center, LLP

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.
March 15, 2024

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.
October 31, 2024

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.
December 15, 2024

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).
February 23, 2024

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.
March 11, 2024

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.
March 19, 2024

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.
March 25, 2025

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.
February 20, 2025

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, 2024

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.
  • LMRC-Aprepitant-Pain-01

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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