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

Primary Purpose

Chronic Pelvic Pain

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Fuke Qianjin capsule

Placebo oral capsule

About this trial

This is an interventional treatment trial for Chronic Pelvic Pain focused on measuring Fuke Qianjin capsule, chronic pelvic pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Lei LiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fuke Qianjin capsule

Placebo oral capsule

Arm Description

Fuke Qianjin capsule, 2 pills each time,three times a day, orally (0.4g/pill）,for 2months,

placebo pills, 2 pills each time,three times a day, orally, for 2months

Outcomes

Primary Outcome Measures

Visual Analogue Scale Score(VAS score) of pelvic pain

pelvic pain degree related assessment

C-reaction protein(CRP)

inflammation response biomarker assessment

Interleukin 6 (IL-6)

pro-inflammatory cytokine assessment

Tumor necrosis factor alpha (TNFα)

systemic inflammation biomarker assessment

Secondary Outcome Measures

The Short Form (36) Health Survey (SF-36)

health status measure

Short-form McGill Pain Questionnaire (SF-MPQ)

pain assessment

Full Information

NCT ID

NCT03251560

First Posted

August 13, 2017

Last Updated

February 2, 2018

Sponsor

Aijun Sun

Collaborators

Second Hospital of Jilin University, Shenzhen maternal and child health care hospital, Guangzhou Women and Children's Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03251560

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2016 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Aijun Sun

Collaborators

Second Hospital of Jilin University, Shenzhen maternal and child health care hospital, Guangzhou Women and Children's Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pelvic Pain

Keywords

Fuke Qianjin capsule, chronic pelvic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

half of the participants will receive Fuke Qianjin capsule, the other half participants will receive placebo

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fuke Qianjin capsule

Arm Type

Experimental

Arm Description

Fuke Qianjin capsule, 2 pills each time,three times a day, orally (0.4g/pill）,for 2months,

Arm Title

Placebo oral capsule

Arm Type

Placebo Comparator

Arm Description

placebo pills, 2 pills each time,three times a day, orally, for 2months

Intervention Type

Drug

Intervention Name(s)

Fuke Qianjin capsule

Intervention Description

Fuke Qianjin capsule 0.8g pills by mouth, three times daily

Intervention Type

Drug

Intervention Name(s)

Placebo oral capsule

Intervention Description

Placebo oral capsule 0.8g pill by mouth, three times daily

Primary Outcome Measure Information:

Title

Visual Analogue Scale Score(VAS score) of pelvic pain

Description

pelvic pain degree related assessment

Time Frame

5 minutes

Title

C-reaction protein(CRP)

Description

inflammation response biomarker assessment

Time Frame

5 minutes

Title

Interleukin 6 (IL-6)

Description

pro-inflammatory cytokine assessment

Time Frame

5 minutes

Title

Tumor necrosis factor alpha (TNFα)

Description

systemic inflammation biomarker assessment

Time Frame

5 minutes

Secondary Outcome Measure Information:

Title

The Short Form (36) Health Survey (SF-36)

Description

health status measure

Time Frame

5 minutes

Title

Short-form McGill Pain Questionnaire (SF-MPQ)

Description

pain assessment

Time Frame

5 minutes

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lei Li, MD

Phone

13911988831

Ext

+86

lileigh@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aijun Sun, MD

Organizational Affiliation

Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lei Li

City

Beijing

State/Province

China/Beiing

ZIP/Postal Code

100000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lei L Li, MD

Phone

13911988831

Ext

+86

lileigh@163.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Network platform, and the website will be attached later.

IPD Sharing Time Frame

Within 2 months after the trial complete

IPD Sharing Access Criteria

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

Citations:

PubMed Identifier

25162265

Citation

Steege JF, Siedhoff MT. Chronic pelvic pain. Obstet Gynecol. 2014 Sep;124(3):616-629. doi: 10.1097/AOG.0000000000000417.

Results Reference

background

Links:

URL

https://www.uptodate.com/contents/causes-of-chronic-pelvic-pain-in-women?source=Out%20of%20date%20-%20zh-Hans&search=%E6%85%A2%E6%80%A7%E7%9B%86%E8%85%94%E7%82%8E&selectedTitle=4~150

Description

Causes of chronic pelvic pain in women

Learn more about this trial

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

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