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Protocol for a Randomized Controlled Trial of Qiling Xiao Zheng Formula Combined with Dydrogesterone in the Treatment of Endometriosis

Protocol for a Randomized Controlled Trial of Qiling Xiao Zheng Formula Combined with Dydrogesterone in the Treatment of Endometriosis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001694
Enrollment
Unknown
Registered
2026-07-06
Start date
2026-05-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Endometriosis

Interventions

Dienogest group:Oral drospirenone
Dienogest combined with Qili XIAOZHENG Formula group:Oral drospirenone in combination with Qiling Xiao Zheng Formula (a traditional Chinese medicine formula)

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1)Clinically or surgically diagnosed with endometriosis, accompanied by dysmenorrhea, pelvic pain, or dyspareunia, with a VAS score =3, ovarian endometriotic cyst diameter =2 cm and =6 cm, including those with surgical indications who, after detailed communication, have no intention of undergoing surgery; 2) Diagnosed in traditional Chinese medicine as "qi deficiency and blood stasis syndrome" related to endometriosis-associated pain; 3) Age =18 years, not postmenopausal, with regular menstrual cycles (21–35 days); 4) Negative urine pregnancy test before enrollment, with contraception during treatment; 5) Have follow-up conditions, able to comply with medical advice for medication and regular follow-up; 6) Signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Use of sex hormone medications within the past 3 months prior to enrollment; 2. Women with other gynecological diseases, such as post pelvic inflammatory disease sequelae or gynecological malignancies; 3. Lactating women; 4. Patients with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system diseases, or malignant tumors; patients with mental disorders; or individuals with a history of severe drug allergies or allergies to known drug components; 5. Patients planning to undergo surgical treatment or other treatment regimens in the near future; 6. Patients currently participating in or who have participated in other clinical trials within the past 3 months prior to this study.

Design outcomes

Primary

MeasureTime frame
Ovarian endometrioma volume;Serum CA125 Level;

Secondary

MeasureTime frame
Traditional Chinese Medicine (TCM) Syndrome Score Scale;Endometriosis-Associated Pain Visual Analog Scale (VAS) Score;

Countries

China

Contacts

Public ContactMiao Yuxi

Guangdong Provincial Hospital of Traditional Chinese Medicine

liangxuefang@gzucm.edu.cn13926082916

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026