The Clinical Effect of Fuke Qianjin Capsule on Chronic Pe... | NCT03251560

Studies
The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation

NCT03251560

Sponsor

Aijun Sun

Status

Unknown status

Last Update Posted

Feb 5, 2018Actual

Enrollment

240Estimated

Phase

Phase 2

Conditions

Chronic Pelvic Pain

Interventions

Fuke Qianjin capsule
Placebo oral capsule

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2016Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2018Estimated

First Submitted Date

Aug 13, 2017

First Submission Date that Met QC Criteria

Aug 13, 2017

First Posted Date

Aug 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2018

Last Update Posted Date

Feb 5, 2018Actual

Name	Class
Second Hospital of Jilin University	OTHER
Shenzhen maternal and child health care hospital	UNKNOWN
Guangzhou Women and Children's Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fuke Qianjin capsule	Experimental	Fuke Qianjin capsule, 2 pills each time,three times a day, orally (0.4g/pill）,for 2months,	Drug: Fuke Qianjin capsule
Placebo oral capsule	Placebo Comparator	placebo pills, 2 pills each time,three times a day, orally, for 2months	Drug: Placebo oral capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fuke Qianjin capsule	Drug	Fuke Qianjin capsule 0.8g pills by mouth, three times daily	Fuke Qianjin capsule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analogue Scale Score(VAS score) of pelvic pain	pelvic pain degree related assessment	5 minutes
C-reaction protein(CRP)	inflammation response biomarker assessment	5 minutes
Interleukin 6 (IL-6)	pro-inflammatory cytokine assessment	5 minutes
Tumor necrosis factor alpha (TNFα)	systemic inflammation biomarker assessment	5 minutes

Secondary Outcomes

Measure	Description	Time Frame
The Short Form (36) Health Survey (SF-36)	health status measure	5 minutes
Short-form McGill Pain Questionnaire (SF-MPQ)	pain assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Lei Li, MD	Contact	13911988831	+86	lileigh@163.com

Name	Affiliation	Role
Aijun Sun, MD	Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Lei Li	Recruiting	Beijing	China/Beiing	100000	China

PubMed Identifier	Type	Citation	Retractions
25162265	Background	Steege JF, Siedhoff MT. Chronic pelvic pain. Obstet Gynecol. 2014 Sep;124(3):616-629. doi: 10.1097/AOG.0000000000000417.

Label	URL
Causes of chronic pelvic pain in women	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Network platform, and the website will be attached later.

Types

Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Within 2 months after the trial complete

Access Criteria

Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.

URL

Not provided