A randomized controlled trial for Yi-Sheng Xiao-Zheng granules in the treatment of dysmenorrhea caused by pelvic endometriosis (syndrome of kidney deficiency and blood stasis)

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR1900002773

Enrollment

Unknown

Registered

2019-11-23

Start date

2018-04-16

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Endometriosis

Interventions

Control group:Simulator of Yi-Shen Xiao-Zheng granules

Experimental group:Yi Shen Xiao Zheng granules

Eligibility

Sex/Gender

Female

Age

20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. diagnosis of pelvic endometriosis; 2. dysmenorrhea symptom score >=7.5 points; 3. syndrome differentiation of traditional Chinese medicine for kidney deficiency and blood stasis; 4. aged 20-45 years (including 20 and 45 years); 5. voluntary signing of informed consent; 6. Those who sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: (1) Patients with ovarian cancer, pelvic inflammatory mass, adenomyosis, uterine fibroids>4cm, primary dysmenorrhea, or intrauterine contraceptive device; (2) Those who have recieved the treatment of endometriosis drugs or other therapies (including laparoscopic) in the last 3 months; (3) Ovarian chocolate cyst diameter>5cm; (4) Hemoglobin<90g/L; (5) Patients with severe cardiovascular diseases and liver diseases: ALT and AST are higher than normal, kidney diseases;BUN and Scr are higher than normal; (6)Allergy or allergy to this experimental drug; (7) Pregnancy, lactation women, or the near future pregnancy plan, can not ensure that during the use of drugs and drug use after the end of a month to take effective contraceptive measures of patients; (8) People who suffer from any serious psychological and mental abnormalities and cannot follow the procedures and norms of clinical trials; (9) Patients whom the doctor deems unfit to participate in clinical trials; (10) Patients who use ibuprofen with caution, including gastrointestinal diseases, including renal insufficiency, high blood pressure, cardiac insufficiency, gastrointestinal ulcers, hemophilia or other hemorrhagic diseases (including coagulation or platelet dysfunction) and bronchial asthma.

Design outcomes

Primary

Measure	Time frame
NRS score;	—

Secondary

Measure	Time frame
Chinese Symdrom Score;	—

Countries

China

Contacts

Public ContactGong Xin

zhongxiyigongxin@163.com+86 18618223766

Outcome results

None listed

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