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

NCT05522634 | Unknown Early Phase 1

• 1 other identifier: TJ-IRB20220634-POI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Ovarian Failure

Keywords

Premature Ovarian Failure; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• serum AMH

  6 months

Study Arms (1)

TJAOA101

EXPERIMENTAL

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

Interventions

TJAOA101 DRUG

Once enrolled, participants will be administrated TJAOA101

TJAOA101

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The age range of patient is 18-40 years old.
• 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)
• Sign the informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Shixuan Wang, Professor

  Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Shixuan Wang, Professor

CONTACT

+8613995553319; shixuanwang@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

CN (1)