A Muticenter Clinical Study of Chinese Herbal Compound TJAOA102 in Alleviating Menopausal Syndrome

NCT05522621 | Unknown Early Phase 1

• 1 other identifier: TJ-IRB20220634-MS
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Currently, TCM recipes are widely used in treating menopausal syndrome(MS) with obvious efficiency and slight side effects. We have developed the Chinese herbal compound TJAOA102 and has validated its effects in animals. Here, we will perform a population-based, multicenter study to confirm the safety and efficacy of TJAOA102 in therapy of MS, which will provide a solid evidence for TCM in therapy of MS.

Conditions

Menopausal Syndrome

Keywords

Menopausal Syndrome; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Evaluating the change of Kupperman Index Score（KMI）

  Assessing the KMI before and after the treatment of TJAOA102

  6 months

Secondary Outcomes (1)

• recovery rate of ovarian function

  6 months

Study Arms (1)

TJAOA102

EXPERIMENTAL

Once enrolled, participants will be administrated TJAOA102 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: TJAOA102

Interventions

TJAOA102 DRUG

Once enrolled, participants will be administrated TJAOA102

TJAOA102

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The age range of patient is 18-55 years old.
• The diagnosis of women is DOR, POI, early menopause or menopausal syndrome, and wish to improve ovarian function or menopausal syndrome.
• Sign the informed consent form.

You may not qualify if:

• (1) The patient is known to be allergic or unsuitable for the Chinese herbal compound. (2) Women who are pregnant and lactating.
• (3) Patients of POI or DOR had been menopause for more than 1 year. (4) Abnormal uterine bleeding, except ovulation disorders. (5) Women who is taking hormone drugs and has stopped taking them within 3 months; (6) The diagnosis of women is 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) The diagnosis of women is 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 who are participating in other clinical trials or have participated in other clinical trials within the last month.
• (11) Patients who are unsuitable for the study evaluated by the investigator.

Sponsors & Collaborators

• Tongji Hospital: lead

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: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: August 31, 2022

Record last verified: 2022-08