DysmenorrheaPhase 4NCT02031523
Multi-center Clinical Trials of Sanjie Analgesic Capsule in Treating Endometriosis
A Phase 4 study testing Sanjie analgesic capsule in people with Dysmenorrhea, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 14 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Sanjie analgesic capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 14 sitesChina
- Study dates
- Oct 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Beijing ChaoYang Hospital
Beijing, Beijing Municipality, 100020
Zhang Zhenyu, M.D., zhengyuzhang2000@yahoo.com
Zhang Zhenyu, M.D.
- Recruiting
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing, Beijing Municipality, 100026
Duan Hua, M.D., duanhua888@163.com
Duan Hua, M.D.
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Zhou Yingfang, M.D., zhouyf8853@yahoo.com.cn
Zhou Yingfang, M.D.
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Leng Jinhua, M.D., lengjenny@vip.sina.com
Lang Jinghe, Doctor
- Recruiting
The General Hospital of People's Liberation Army
Beijing, Beijing Municipality, 100853
Guan Zheng, Master, GZ9332@yahoo.com.cn
Guan Zheng, Master
- Recruiting
The First Hospital of Hunan University of chinese Medicine
Changsha, Hunan, 410000
Lin Jie, 379327931@qq.com
Lin Jie
- Recruiting
The Maternal and Child Health Hospital of Hunan Province
Changsha, Hunan, 41008
Gong Yingping, 13973139188
Gong Yingping
- Recruiting
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
Lin Jun, Bachelor, linjun@zju.edu.cn
Lin Jun, Bachelor
- Recruiting
Guangxing Hospital Of Zhejiang Chinese Medicine University
Hangzhou, Zhejiang, 31007
Zhang Qin, Zhqin@zjwh.gov.cn
Zhang Qin
- Recruiting
Jinan municipal hospital of Traditional Chinese Medicine
Jinan, Shandong, 250012
Tang Ye, 13589018957
Tang Ye
- Recruiting
The Second Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 25001
Sun Wei, 839580089@qq.com
Sun Wei
- Recruiting
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
Zhang Shaofen, Bachelor, zhangshaofen@163.com
Zhang Shaofen, Bachelor
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Zhang Shulan, Master, zsl0909@sina.com
Zhang Shulan, Master
- Recruiting
Hubei Provincal Hospital of TCM
Wuhan, Hubei, 430061
Zhou zhongming, 379327931@qq.com
Zhou Zhongming
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Post-marketing Study to Assess the Treatment Effect of Sanjie Analgesic Capsule in Treating Endometriosis - Associated Pain
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.
Read the detailed description
Sanjie Analgesic Capsule is a Chinese Traditional Patent Medicine. It is a botanical extract from the raw materials of the Resina Draconis , Panax Notoginseng, fritillary bulb and coix seed, which are derived from a classic prescription of traditional Chinese medicine.
Sanjie Analgesic Capsule was approved by CFDA in 2004, produced by means of modern technology by Jiangsu Kanion Pharmaceutical Co., Ltd. The study is a multi-center, double -blind, placebo-controlled, randomized 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.
- Conditions
- Dysmenorrhea
- Being tested
- Sanjie analgesic capsule, placebo
- Keywords
- endometriosis, dysmenorrhea, Sanjie analgesic capsule, effect/safety
- Medical subject headings
- Dysmenorrhea, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sanjie analgesic capsuleDrug
Also called Jiangsu Kanion Pharmaceutical Co.,Ltd
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.
placeboDrug
Also called Jiangsu Kanion Pharmaceutical Co.,Ltd
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.
| Study group | Role | What they receive |
|---|---|---|
| Sanjie analgesic capsule | Active comparator | every 4 capsules , 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. Receives: Drug: Sanjie analgesic capsule |
| placebo | Placebo comparator | every 4 capsules, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
dysmenorrhea
Measured: Baseline, 1,2,3,4 menstrual cycle
Secondary outcomes (9)
change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge )
Measured: baseline，1,2,3,4 menstrual cycle
change of Signs(Pelvic-tenderness Tubercle )
Measured: baseline，1,2,3,4 menstrual cycle
change of Menstrual cycle and quantity
Measured: baseline，1,2,3,4 menstrual cycle
change of serum CA125
Measured: baseline,3,4 menstrual cycle
the size of uterus and endometriosis cyst
Measured: baseline,3,4 menstrual cycle
change of serum endocrinological hormone
the content of FSH, LH, E2, PRL, P, T
Measured: baseline,3,4 menstrual cycle
change of SF-36 score
Measured: Baseline,3 menstrual cycle
Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests
Measured: Baseline,3 menstrual cycle
Safety assessments will be based on adverse event reports
Measured: 1,2,3 menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Bionovo Medicine Development Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Lang Jinghe, Doctor, Principal investigator, Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031523
- Sponsor's protocol ID
- NO.2-20130301
- Status last verified
- Dec 2013
- First submitted
- 16 Dec 2013
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39046647
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Post-marketing Study to Assess the Treatment Effect of Sanjie Analgesic Capsule in Treating Endometriosis - Associated Pain
- ClinicalTrials.gov ID
- NCT02031523
- Acronym / sponsor ID
- NO.2-20130301
- Conditions
- Dysmenorrhea
- Keywords
- endometriosis, dysmenorrhea, Sanjie analgesic capsule, effect/safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Bionovo Medicine Development Co., Ltd.
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sanjie Analgesic Capsule is a Chinese Traditional Patent Medicine. It is a botanical extract from the raw materials of the Resina Draconis , Panax Notoginseng, fritillary bulb and coix seed, which are derived from a classic prescription of traditional Chinese medicine.
Sanjie Analgesic Capsule was approved by CFDA in 2004, produced by means of modern technology by Jiangsu Kanion Pharmaceutical Co., Ltd. The study is a multi-center, double -blind, placebo-controlled, randomized 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sanjie analgesic capsule | Active comparator | Drug: Sanjie analgesic capsuleevery 4 capsules , 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. |
| placebo | Placebo comparator | Drug: placeboevery 4 capsules, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sanjie analgesic capsuleAlso: Jiangsu Kanion Pharmaceutical Co.,LtdOral, 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. | Drug | Sanjie analgesic capsule |
| placeboAlso: Jiangsu Kanion Pharmaceutical Co.,Ltdoral，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. | Drug | placebo |
Primary outcome
dysmenorrhea
Time frame: Baseline, 1,2,3,4 menstrual cycle
9 secondary outcomes
change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge )
Time frame: baseline，1,2,3,4 menstrual cycle
change of Signs(Pelvic-tenderness Tubercle )
Time frame: baseline，1,2,3,4 menstrual cycle
change of Menstrual cycle and quantity
Time frame: baseline，1,2,3,4 menstrual cycle
change of serum CA125
Time frame: baseline,3,4 menstrual cycle
the size of uterus and endometriosis cyst
Time frame: baseline,3,4 menstrual cycle
change of serum endocrinological hormone
Time frame: baseline,3,4 menstrual cycle
change of SF-36 score
Time frame: Baseline,3 menstrual cycle
Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests
Time frame: Baseline,3 menstrual cycle
Safety assessments will be based on adverse event reports
Time frame: 1,2,3 menstrual cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
- Derived from this study: PubMed 39046647Leng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing, China
Lang Jinghe, Doctor principal investigator
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sanjie analgesic capsule in people with Dysmenorrhea, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dysmenorrhea (time frame: Baseline, 1,2,3,4 menstrual cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02031523, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.