A Clinical Study of Chinese Herbal Compound TJAOA101 in the Treatment of Premature Ovarian Insufficiency

The Efficacy and Safety of Chinese Herbal Compound TJAOA101 in the Treatment of POI: A Multicenter, Prospective and Before-after Study.

Premature ovarian insufficiency (POI) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating POI. We have created a new Chinese herbal combination TJAOA101, whereas its safety and efficacy still need to be validated. Hence, we will perform a population-based, multicenter study to confirm the safety and efficacy of TJAOA101 in therapy of POI. We aim to provide a solid evidence for TCM in therapy of POI.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Ovarian Failure
• Intervention / Treatment: Drug: TJAOA101

Detailed Description

Premature ovarian insufficiency (POI) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating POI. We have created a new Chinese herbal combination TJAOA101, whereas its safety and efficacy still need to be validated in multi-center and prospective clinical trials. We are conducting a prospective and before-after clinic trial with 100 eligible women aged 18-40 diagnosed POI will be participated. All participants will be administrated TJAOA101 drug twice every day for overall 3 months. The primary outcomes will be the basal level of serum FSH. The second outcome is the recovery rate of menstruation. All the outcomes will be assessed at baseline and 1, 2, 3 months following the 3 months' treatment. Adverse events(AEs) of patients will be assessed during the follow-up. The study was approved by the Medical Ethics Committee of the Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology (TJ-IRB20220634) according to the submitted study protocol (V.2.1, 10 May 2022) and informed consent (V.2.1, 10 May 2022). The results will be presented at domestic and international conferences and published in peer reviewed journals.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Wuhan, China
    • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. The age range of patient is 18-40 years old.
2. The diagnostic criteria for POI is as follows: Age <40; and menopause or sporadic menstruation for more than 4 months; and bFSH>25 mIU/ml (the interval between two reexaminations should be more than one month, both reached this level)
3. Sign the informed consent form.

Exclusion Criteria:

1. Patient is known to be allergic or unsuitable for the Chinese herbal compound.
2. Women who are pregnant and lactating.
3. Patients had been menopause for more than 1 year.
4. Abnormal uterine bleeding, except ovulation disorders.
5. Women is taking hormone drugs and has stopped taking them within 3 months;
6. Women with endometriosis, myadenosis, submucosal fibroids or the size of non- submucosal fibroids is more than 4 cm.
7. The nature of pelvic mass is unknown.
8. Women with polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, diabetes, thyroid and adrenal dysfunction and other endocrine diseases affecting ovulation.
9. Patients with serious primary diseases such as cardiovascular, liver, kidney, lung, biliary, hematopoietic system (Hb<90g/L) and malignant tumor, and psychiatric patients.
10. Patients are participating in other clinical trials or have participated in other clinical trials within the last month.
11. Unsuitable for the study evaluated by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TJAOA101; Once enrolled, participants will be administrated TJAOA101 and followed by a 3-month medication cycle. The usage of this herbal compound is to take orally twice a day(two sacks per). Add it to about 200ml warm water and take it half an hour before breakfast in the morning and half an hour before bedtime in the evening except menstrual period.	Drug: TJAOA101; Once enrolled, participants will be administrated TJAOA101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recovery rate of ovarian function	As the definition of POI is based on menstruation and bFSH, the recovery of ovarian function is also based on the recovery of these indicators. In this study, the recovery of ovarian function is defined as serum bFSH decreased more than 50%, or recover to normal level; or two consecutive periods return to normal.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum AMH	serum AMH increased more than 50%, or recover to normal level.	6 months

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2022
• Primary Completion (ANTICIPATED): November 1, 2023
• Study Completion (ANTICIPATED): November 1, 2024

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (ACTUAL): August 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Premature Ovarian Failure
• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: TJ-IRB20220634-POI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No