Chronic Pelvic PainPhase 2NCT03251560
The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation
A Phase 2 study testing Fuke Qianjin capsule in people with Chronic Pelvic Pain, run by Aijun Sun at 1 site in China.
Trial summary
A prospective random control clinical trials to research Fuke Qianjin capsule's effects on ameliorating the pain caused by chronic pelvic disease. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- Fuke Qianjin capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 31 Dec 2018
- Phase
- Phase 2
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subject is a female between the age of 18 and 50.
- Subject with a history of pelvic inflammatory disease suffered from one of the symptoms below and one of the signs below: symptoms:1.lower abdominal distension or pain;2.lumbosacral soreness. signs:1. enlarged,cable strip-like fallopian tube with mild tenderness palpated on one side or both sides of the uterine;2.restricted movement or adhesion fixed of the uterine;3.the sacral ligaments thicken and harden with mild tenderness.
- Subject VAS score of pelvic pain ≥4
- Subject without fertility requirements in 2 months
- Subject provides written informed consent.
Who cannot join
- Subject underwent recurrent urinary system infection or interstitial cystitis
- Subject underwent irritable bowel syndrome
- Subject has other complications in addition to chronic pelvis inflammation diseases leading to chronic pelvic pain,such as gynecological malignant disease,irregular vaginal bleeding, endometriosis,adenomyosis,ovarian neoplasm with a diameter >5cm by ultrasound
- Subject is pregnant or lactating.
- Subject has a severe systemic disease, such as cardiovascular system
- Subject has a history of malignancy or radiotherapy.
Show all 10Show fewer
- Subject has undergone any chronic pelvic pain treatment including antibiotics,paregoric,physiotherapy or any other related treatment within 1month prior to randomization.
- Subject has mental disorder incapable of elementary cooperations.
- Subject has an allergic history to the experimental drug.
- Subject has participated in other clinical researches of medicine within 1month prior to randomization.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, China/Beiing, 100000
Lei L Li, MD, 13911988831 ext. +86, lileigh@163.com
About this study
A prospective random control clinical trials to research Fuke Qianjin capsule's effects on ameliorating the pain caused by chronic pelvic disease.
Read the detailed description
Fuke Qianjin capsule has been widely used in clinical medicine to ameliorate the pain caused by chronic pelvic disease.But random control trials on its effects are few.Our study was designed as a prospective random control clinical trials to research its effects.
- Conditions
- Chronic Pelvic Pain
- Being tested
- Fuke Qianjin capsule, Placebo oral capsule
- Keywords
- Fuke Qianjin capsule, chronic pelvic pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuke Qianjin capsuleDrug
Fuke Qianjin capsule 0.8g pills by mouth, three times daily
Placebo oral capsuleDrug
Placebo oral capsule 0.8g pill by mouth, three times daily
| Study group | Role | What they receive |
|---|---|---|
| Fuke Qianjin capsule | Experimental | Fuke Qianjin capsule, 2 pills each time,three times a day, orally (0.4g/pill）,for 2months, Receives: Drug: Fuke Qianjin capsule |
| Placebo oral capsule | Placebo comparator | placebo pills, 2 pills each time,three times a day, orally, for 2months Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale Score(VAS score) of pelvic pain
pelvic pain degree related assessment
Measured: 5 minutes
C-reaction protein(CRP)
inflammation response biomarker assessment
Measured: 5 minutes
Interleukin 6 (IL-6)
pro-inflammatory cytokine assessment
Measured: 5 minutes
Tumor necrosis factor alpha (TNFα)
systemic inflammation biomarker assessment
Measured: 5 minutes
Secondary outcomes (2)
The Short Form (36) Health Survey (SF-36)
health status measure
Measured: 5 minutes
Short-form McGill Pain Questionnaire (SF-MPQ)
pain assessment
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Dec 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2018 (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 Chronic Pelvic PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- half of the participants will receive Fuke Qianjin capsule, the other half participants will receive placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aijun Sun
- Sponsor type
- University, hospital or other
- Collaborators
- Second Hospital of Jilin University, Shenzhen maternal and child health care hospital, Guangzhou Women and Children's Medical Center
- Responsible party
- Sponsor-investigator, Aijun Sun, Peking Union Medical College Hospital
- Investigators
- Aijun Sun, MD, Principal investigator, Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251560
- Sponsor's protocol ID
- PID201706
- Status last verified
- Feb 2018
- First submitted
- 13 Aug 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Network platform, and the website will be attached later.
Publications
Steege JF, Siedhoff MT. Chronic pelvic pain. Obstet Gynecol. 2014 Sep;124(3):616-629. doi: 10.1097/AOG.0000000000000417.
PubMed 25162265
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation
- ClinicalTrials.gov ID
- NCT03251560
- Acronym / sponsor ID
- PID201706
- Conditions
- Chronic Pelvic Pain
- Keywords
- Fuke Qianjin capsule, chronic pelvic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Aijun SunUniversity, hospital or other
- Collaborators
- Second Hospital of Jilin University, Shenzhen maternal and child health care hospital, Guangzhou Women and Children's Medical Center
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 16 Aug 2017 (actual)
- 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.
A prospective random control clinical trials to research Fuke Qianjin capsule's effects on ameliorating the pain caused by chronic pelvic disease.
Detailed description
Fuke Qianjin capsule has been widely used in clinical medicine to ameliorate the pain caused by chronic pelvic disease.But random control trials on its effects are few.Our study was designed as a prospective random control clinical trials to research its effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- half of the participants will receive Fuke Qianjin capsule, the other half participants will receive placebo
| Arm | Type | Receives |
|---|---|---|
| Fuke Qianjin capsule | Experimental | Drug: Fuke Qianjin capsuleFuke Qianjin capsule, 2 pills each time,three times a day, orally (0.4g/pill）,for 2months, |
| Placebo oral capsule | Placebo comparator | Drug: Placebo oral capsuleplacebo pills, 2 pills each time,three times a day, orally, for 2months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is a female between the age of 18 and 50.
- Subject with a history of pelvic inflammatory disease suffered from one of the symptoms below and one of the signs below: symptoms:1.lower abdominal distension or pain;2.lumbosacral soreness. signs:1. enlarged,cable strip-like fallopian tube with mild tenderness palpated on one side or both sides of the uterine;2.restricted movement or adhesion fixed of the uterine;3.the sacral ligaments thicken and harden with mild tenderness.
- Subject VAS score of pelvic pain ≥4
- Subject without fertility requirements in 2 months
- Subject provides written informed consent.
Key exclusion criteria (10 listed)
- Subject underwent recurrent urinary system infection or interstitial cystitis
- Subject underwent irritable bowel syndrome
- Subject has other complications in addition to chronic pelvis inflammation diseases leading to chronic pelvic pain,such as gynecological malignant disease,irregular vaginal bleeding, endometriosis,adenomyosis,ovarian neoplasm with a diameter >5cm by ultrasound
- Subject is pregnant or lactating.
- Subject has a severe systemic disease, such as cardiovascular system
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 |
|---|---|---|
| Fuke Qianjin capsuleFuke Qianjin capsule 0.8g pills by mouth, three times daily | Drug | Fuke Qianjin capsule |
| Placebo oral capsulePlacebo oral capsule 0.8g pill by mouth, three times daily | Drug | Placebo oral capsule |
Primary outcome
Visual Analogue Scale Score(VAS score) of pelvic pain
Time frame: 5 minutes
pelvic pain degree related assessment
C-reaction protein(CRP)
Time frame: 5 minutes
inflammation response biomarker assessment
Interleukin 6 (IL-6)
Time frame: 5 minutes
pro-inflammatory cytokine assessment
Tumor necrosis factor alpha (TNFα)
Time frame: 5 minutes
systemic inflammation biomarker assessment
2 secondary outcomes
The Short Form (36) Health Survey (SF-36)
Time frame: 5 minutes
Short-form McGill Pain Questionnaire (SF-MPQ)
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Background: PubMed 25162265Steege JF, Siedhoff MT. Chronic pelvic pain. Obstet Gynecol. 2014 Sep;124(3):616-629. doi: 10.1097/AOG.0000000000000417.
- Causes of chronic pelvic pain in womenLink provided by the sponsor.
- Chronic Pelvic Inflammatory DiseaseLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Network platform, and the website will be attached later.
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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.
Aijun Sun, MD principal investigator
Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fuke Qianjin capsule in people with Chronic Pelvic Pain, run by Aijun Sun at 1 site 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 10 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Lei Li, MD (13911988831 ext. +86, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale Score(VAS score) of pelvic pain (time frame: 5 minutes). The study lists 4 primary outcomes in all. 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 NCT03251560, 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 5 Feb 2018.