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Modified Gegen Qinlian formula granule and traditional decoction improved ovulation rate in patients with PCOS-IR :A Randomized controlled study

Registration number：

ITMCTR2025000007

Date of Last Refreshed on：

2025-01-03

Date of Registration：

2025-01-03

Registration Status：

Prospective registration

Public title：

Modified Gegen Qinlian formula granule and traditional decoction improved ovulation rate in patients with PCOS-IR :A Randomized controlled study

English Acronym：

Scientific title：

Modified Gegen Qinlian formula granule and traditional decoction improved ovulation rate in patients with PCOS-IR :A Randomized controlled study

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Jian Liu

Study leader：

Jian Liu

Applicant telephone：

15802034064

Study leader's telephone：

15802034064

Applicant Fax：

Study leader's fax：

Applicant E-mail：

jianliu@gzucm.edu.cn

Study leader's E-mail：

jianliu@gzucm.edu.cn

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

111 Dade Road Yuexiu District Guangzhou Guangdong

Study leader's address：

111 Dade Road Yuexiu District Guangzhou Guangdong

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

广东省中医院伦理委员会BF2024-235-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

Date of approved by ethic committee：

2024/9/10 0:00:00

Contact Name of the ethic committee：

Xiaoyan Li

Contact Address of the ethic committee：

111 Dade Road Yuexiu District Guangzhou Guangdong

Contact phone of the ethic committee：

020-81887233转35943

Contact email of the ethic committee：

llbgs@gzucm.edu.cn

Primary sponsor：

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Primary sponsor's address：

111 Dade Road Yuexiu District Guangzhou Guangdong

Secondary sponsor：

Country：

The People's Republic of China

Province：

Guangdong Province

City：

Institution
hospital：

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Address：

111 Dade Road Yuexiu District Guangzhou Guangdong

Source(s) of funding：

Guangdong Hospital of Traditional Chinese Medicine

5A80.1

Target disease：

PCOS

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

(1) A randomized controlled study focused on PCOS patients with insulin resistance and compared with metformin to evaluate the effectiveness of modified Gegenqinlian Decoction in improving insulin resistance and promoting ovulation in PCOS patients; The adverse reactions and adverse events were analyzed to highlight the advantages of safety and provide clinical evidence-based evidence for the treatment of PCOS by traditional Chinese medicine. (2) A randomized controlled study was conducted to evaluate and compare the consistency of the efficacy and safety of modified Gegen Qinlian Decoction formula granules and traditional decoction pieces in improving insulin resistance and promoting ovulation in PCOS patients providing strong evidence for the comparison between classical prescription formula granules and decoction pieces.

Description for medicine or protocol of treatment in detail：

(1)Basic Treatment: Lifestyle Intervention (2) Intervention Grouping ① Treatment Group of Traditional Chinese Medicine Formula Granules: On the basis of lifestyle intervention patients should take the formula granules of Modified Gegen Qinlian Decoction (Gegen Scutellaria baicalensis Huanglian etal). Provided by Yifang Pharmaceutical one pack each time dissolved and flushed with 100ml warm water once a day for a total of 12 weeks. ② Treatment Group of Traditional Chinese Medicine Decoction Pieces : On the basis of lifestyle intervention patients in this group should take the Modified Gegen Qinlian Decoction traditional Chinese medicine decoction pieces. The decoction pieces all adopted standardized decoction technology 2 times a day 1 pack each time. ③ Metformin control group: On the basis of lifestyle intervention patients took metformin sustained-release tablets. According to the patient's insulin resistance 0.5 - 1 g each time once a day with meals. Take a total of 12 weeks. Both groups started to take the drug on the first 1 - 3 days of menstruation.

Inclusion criteria

1: People with the diagnostic criteria included PCOS and insulin resistance 2: Aged18-39 years old 3: Voluntary signing of informed consent

Exclusion criteria：

1: People with Congenital adrenal hyperplasia or history of androgen secreting tumors 2: People with Cushing's syndrome 3: People with hyperprolactinemia and thyroid dysfunction 4: Body mass index (BMI)≥35kg/m² 5: Smokers 6: In the last 1 month she has used oral contraceptives (such as danyin-35) and insulin sensitizers (such as dimethyldiquide pilaglitazone) or injected glucagon-like peptide-1 receptor agonists (such as liraglutide dura glycotide etc.) 7: Patients with cardiovascular disease hypertension diabetes liver kidney and other chronic diseases of important organs 8: Patients with fertility requirements during pregnancy lactation and treatment

Study execute time：

From 2023-11-01

To      2026-10-31

Recruiting time：

From 2025-02-01

To      2026-06-30

Interventions：

23

Group：

Metformin control group

Sample size：

Intervention：

Lifestyle Intervention+Metformin

Intervention code：

23

Group：

Chinese medicine traditional decotion treatment group

Sample size：

Intervention：

Lifestyle Intervention+Modified Gegen Qinlian traditional decoction

Intervention code：

23

Group：

Chinese medicine formula granule treatment group

Sample size：

Intervention：

Lifestyle Intervention+Modified Gegen Qinlian formula granules

Intervention code：

Total sample size ： 69

Countries of recruitment
and research settings：

Country：

The People's Republic of China

Province：

Guangdong Province

City：

Institution/hospital：

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Level of the institution：

Outcomes：

Outcome：

Body composition analysis, hirsutism score, acne score

Type：

Secondary indicator

Measure time point of outcome：

once before and after treatment

Measure method：

Hypertrichosis and acne are detected by physical examination and scale, and body composition is measured by body composition analysis instrument

Outcome：

Biochemical indicators (blood sugar, insulin, lipid)

Type：

Secondary indicator

Measure time point of outcome：

once before and after treatment

Measure method：

Serum detection

Outcome：

Ovulation rate

Type：

Primary indicator

Measure time point of outcome：

Transvaginal ultrasound monitoring began on the 12th day of menstruation, and follow-up monitoring was performed according to the development of follicles. Basal body temperature was measured and recorded daily after enrollment.

Measure method：

Transvaginal ultrasound monitoring combined with basal body temperature

Outcome：

Six sex hormones

Type：

Secondary indicator

Measure time point of outcome：

once before and after treatment

Measure method：

Serum detection

Collecting sample(s)
from participants：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
39
Max age years

Recruiting status：

Participant age：

Gender：

Female

Randomization Procedure (please state who generates the random number sequence and by what method)：

The randomized allocation method will be completed by the clinical methodology team of Guangdong Hospital of Chinese Medicine researchers using a simple random method the random plan first wrote a good numerical sequence table (this order is the serial number of qualified subjects entering the clinical trial later) and generated random numbers through the PROCPLAN process programming of SAS9.4 statistical software.

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Contact the author by email

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection and Management (A standard data collection and management system include a CRf and an electronic data capture

Data Managemen Committee：

No

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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