Multi-center Clinical Trials of Sanjie Analgesic Capsule in Treating Endometriosis
A Randomized, Double-blind, Placebo-controlled Post-marketing Study to Assess the Treatment Effect of Sanjie Analgesic Capsule in Treating Endometriosis - Associated Pain
1 other identifier
interventional
400
1 country
14
Brief Summary
It is a multi-center, double -blind, placebo -controlled, randomized post-marketing study in Chinese subjects with endometriosis-associated pain to assess treatment effect and safety in the subjects treated with Sanjie Analgesic Capsule versus subjects treated with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2013
Typical duration for phase_4
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 16, 2013
CompletedFirst Posted
Study publicly available on registry
January 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedNovember 19, 2014
December 1, 2013
2 years
December 16, 2013
November 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
dysmenorrhea
Baseline, 1,2,3,4 menstrual cycle
Secondary Outcomes (9)
change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge )
baseline，1,2,3,4 menstrual cycle
change of Signs(Pelvic-tenderness Tubercle )
baseline，1,2,3,4 menstrual cycle
change of Menstrual cycle and quantity
baseline，1,2,3,4 menstrual cycle
change of serum CA125
baseline,3,4 menstrual cycle
the size of uterus and endometriosis cyst
baseline,3,4 menstrual cycle
- +4 more secondary outcomes
Study Arms (2)
Sanjie analgesic capsule
ACTIVE COMPARATORevery 4 capsules , 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.
placebo
PLACEBO COMPARATORevery 4 capsules, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.
Interventions
Oral, four each time, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.or follow the doctor's advice.
oral，four each time, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. Or Follow the doctor's advice.
Eligibility Criteria
You may qualify if:
- Subjects have a diagnosis of endometriosis by laparoscopy within 5 years prior to signing ICF, main complain of dysmenorrhea (or menstrual pain or painful periods) and with VAS score of 4 or above; Endometriosis combined with uterine adenomyosis is included.
- Female between the ages of 18 and 45 years old;
- Regular menstrual period, menstrual cycle falls in the ranging from 28 to 30 days;
- No pregnancy planning during taking study medication; use (or have their partner use) an acceptable method of birth control within the projected duration of the study ;
- Subjects must sign ICF and agree for follow up.
You may not qualify if:
- Genital cancer or other malignant tumor;
- Adnexal masses≥5cm;
- Uterine myoma≥3cm;
- Suffering from cardiovascular, hepatic, renal or hematopoietic system disease or mental illness;
- Receiving hormone therapy within 3 months prior to signing ICF;
- Receiving surgical treatment for endometriosis within 3 months prior to signing ICF;
- Subjects have a plan of pregnancy, being pregnant, breast-feeding during recent 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Beijing ChaoYang Hospital
Beijing, Beijing Municipality, 100020, China
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing, Beijing Municipality, 100026, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
The General Hospital of People's Liberation Army
Beijing, Beijing Municipality, 100853, China
Hubei Provincal Hospital of TCM
Wuhan, Hubei, 430061, China
The First Hospital of Hunan University of chinese Medicine
Changsha, Hunan, 410000, China
The Maternal and Child Health Hospital of Hunan Province
Changsha, Hunan, 41008, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Jinan municipal hospital of Traditional Chinese Medicine
Jinan, Shandong, 250012, China
The Second Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 25001, China
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011, China
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006, China
Guangxing Hospital Of Zhejiang Chinese Medicine University
Hangzhou, Zhejiang, 31007, China
Related Publications (1)
Leng JH, Duan H, Guan Z, Zhou YF, Qu H, Xu KH, Zhang SF, Zhang Q, Wang X, Lin KQ, Lang JH. Efficacy and Safety of Sanjie Analgesic Capsule in Patients with Endometriosis-Associated Pain: A Multicenter, 3:1 Randomized, Double-Blind, Placebo-Controlled Trial. Chin J Integr Med. 2024 Sep;30(9):780-787. doi: 10.1007/s11655-024-3756-y. Epub 2024 Jul 24.
PMID: 39046647DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lang Jinghe, Doctor
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2013
First Posted
January 9, 2014
Study Start
October 1, 2013
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
November 19, 2014
Record last verified: 2013-12