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Clinical research protocol of Qinlian Duocang granule in the treatment of PCOS IR with stomach heat and spleen deficiency.

Clinical research protocol of Qinlian Duocang granule in the treatment of PCOS IR with stomach heat and spleen deficiency.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058920
Enrollment
Unknown
Registered
2022-04-19
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic ovary syndrome

Interventions

Experimental group:taking metformin
Experimental group:Taking Qinlian Duonang granules
control group:taking metformin
control group:Taking the Simulant Qinlian Duonang granules

Sponsors

Guanganmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Fully understand, know and voluntarily participate in this study and sign the informed consent form; 2. It meets the diagnostic criteria of polycystic ovary syndrome (PCOS) in western medicine; 3. Meet the diagnostic criteria of insulin resistance (IR); 4. Conforming to the syndrome differentiation standard of stomach heat and spleen deficiency in traditional Chinese medicine; 5. 18 = age = 35 years.

Exclusion criteria

Exclusion criteria: 1. Menarche less than 2 years; 2. Patients with other endocrine diseases such as thyroid, adrenal diseases and diabetes; 3. Patients with severe diseases such as cardio-cerebrovascular, liver, kidney and hematopoietic system and thrombotic diseases, and those with serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) or serum creatinine (CREA) greater than 2 times the upper limit of normal reference value. 4. Patients with peptic ulcer or malabsorption syndrome; 5. Patients with mental illness or cancer; 6. Those who have taken hormone drugs (except progesterone), metformin, or traditional Chinese medicine decoction within the past three months, or have accepted other clinical research; 7. Those who are allergic to the ingredients of traditional Chinese medicine, and those with allergic constitution; 8. Alcoholics and/or psychoactive substances, drug abusers and addicts; 9. Pregnancy planners in the last 3 months; 10. Subjects with poor compliance or unable to follow up regularly.

Design outcomes

Primary

MeasureTime frame
Biphasic rate of basal body temperature;Insulin related indexes;

Secondary

MeasureTime frame
Female reproductive hormone;TCM symptom score;Menstruation rate;Related indexes of glucose metabolism;Acanthosis nigricans score;Lipid metabolism level;Anthropometry;Acne score;Quality of life scale for patients with PCOS;SCL-90 scale;Patient self-evaluation;

Countries

China

Contacts

Public ContactXinmin Liu

Guanganmen Hospital, China Academy of Chinese Medical Sciences

beijingliuxm@163.com+86 13651319626

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026