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Randomized positive drug parallel controlled clinical trial on the efficacy and safety of Bazhen Teabag in the treatment of menstrual insufficiency (qi and blood deficiency syndrome)

Randomized positive drug parallel controlled clinical trial on the efficacy and safety of Bazhen Teabag in the treatment of menstrual insufficiency (qi and blood deficiency syndrome)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000070
Enrollment
Unknown
Registered
2025-01-10
Start date
2024-10-31
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Menstrual insufficiency caused by deficiency of qi and blood

Interventions

Treatment Group:Bazhen Teabag
Control Group:Bazhen Wan

Sponsors

Chengdu University of Traditional Chinese Medicine Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for oligomenorrhea; 2. Meet the diagnostic criteria for qi and blood deficiency syndrome; 3. Age between 18 and 40 years old; 4. Agree to conduct clinical trials and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Anyone who falls under any of the following circumstances will not be selected as a subject. 1. Patients with prolonged menstrual periods; 2. Patients with endometrial lesions intrauterine adhesions premature ovarian failure uterine fibroids (larger than 3cm) adenomyosis pituitary tumors and thyroid dysfunction after examination; 3. Those who have used drugs or methods that have therapeutic effects on oligomenorrhea within one month before the study and those who have used hormone drugs and contraceptive pills for treatment within three months; 4. Those with a history or present medical history of serious cardiovascular disease digestive system disease hematopoietic system disease mental and neurological system disease etc. whom the researcher deems unsuitable to participate in this clinical trial; 5. Abnormal liver function (alanine aminotransferase (ALT) aspartate aminotransferase (AST)>1.5 times the upper limit of normal values) abnormal kidney function (creatinine (Cr) blood urea nitrogen (BUN)>normal values) and clinically significant as determined by researchers; 6. Individuals with allergic constitution or multiple drug allergies; 7. Those who plan to conceive during the medication period and within one month after stopping the medication and those who cannot strictly use contraception as required; 8. Patients who are unable to cooperate or are currently participating in other drug trials; 9. Patients with ovarian dysfunction caused by iatrogenic factors; 10. Researchers determine that individuals are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
TCM syndrome curative effect;Pictorial Blood Loss Assessment Chart;

Secondary

MeasureTime frame
Follicle stimulating hormone;Estradiol;Progesterone;Testosterone;Luteinizing hormone;Pituitary prolactin;

Countries

China

Contacts

Public ContactYan Wang

Chengdu University of Traditional Chinese Medicine Affiliated Hospital

quanxin@cqdpt.com028-87783142

Outcome results

None listed

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