ClinicalTrials.gg
Status unknownNCT03251560Updated Feb 5, 2018

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

A Phase 2 interventional study of Fuke Qianjin capsule and Placebo oral capsule in Chronic Pelvic Pain, sponsored by Aijun Sun. Status unknown at 1 site in China. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-02-05.

Sponsored by Aijun Sun · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Dec 2016, registered Aug 2017).
Phase
Phase 2
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 14 studies in Pelvic Pain with a site in China — 5 open to participants now, 5 under way, 1 of them phase 3. Pelvic Pain · China.

Planned enrollment
4th of 12
240 · median 198
Started
2016
the only one that year
Phase 2
2 of 14
none open now
Registered
1st of 14
by date
Lead sponsor
1 of 14
Aijun Sun

Among the 14 studies in Pelvic Pain with a site in China, this one is the 4th largest by planned enrollment of the 12 interventional ones that give a count, is the only one that started in 2016, is one of 2 in phase 2, and was the 1st registered.

Pelvic Pain

376 studies on the registry are indexed under Pelvic Pain; 90 are open to participants now.

Browse Pelvic Pain studies →

Open to participants now

5 of the 14 studies in Pelvic Pain with a site in China are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 60 Pelvic Pain studies recruiting now, 22 (37%) set no upper age limit and 36 (60%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.

This study: 18 Years to 50 Years · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 14 studies in Pelvic Pain with a site in China, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Chronic Pelvic Pain

Browse trials for

Keywords

  • Fuke Qianjin capsule
  • chronic pelvic pain
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Fuke Qianjin capsule

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

    Drug: Fuke Qianjin capsule

  • Placebo comparator
    Placebo oral capsule

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

    Drug: Placebo oral capsule

Interventions

  • DrugFuke Qianjin capsule

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

  • DrugPlacebo oral capsule

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

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale Score(VAS score) of pelvic pain

    pelvic pain degree related assessment

    Time frame: 5 minutes

  2. C-reaction protein(CRP)

    inflammation response biomarker assessment

    Time frame: 5 minutes

  3. Interleukin 6 (IL-6)

    pro-inflammatory cytokine assessment

    Time frame: 5 minutes

  4. Tumor necrosis factor alpha (TNFα)

    systemic inflammation biomarker assessment

    Time frame: 5 minutes

Secondary outcomes

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

    health status measure

    Time frame: 5 minutes

  2. Short-form McGill Pain Questionnaire (SF-MPQ)

    pain assessment

    Time frame: 5 minutes

07

Study locations

1 of 1 sites recruiting
  • Lei Li
    Beijing, China/Beiing 100000, China
    Recruiting
08

References and documents

Publications

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

Individual participant data

Plan to share: Yes — Network platform, and the website will be attached later.

Supporting information: Study protocol, Informed consent form, Clinical study report, 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2016 to primary completion in Dec 2017, 12 months.

Of 14 phase 2 interventional studies under Pelvic Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 29. This study's 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2017
First posted
Aug 16, 2017
StartActual
Dec 1, 2016
Primary completionActual
Dec 31, 2017
CompletionEst.
Dec 31, 2018
Last update
Feb 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03251560
Lead sponsor
Aijun Sun
Collaborators
Second Hospital of Jilin University, Shenzhen maternal and child health care hospital, Guangzhou Women and Children's Medical Center
Responsible party
Aijun Sun (professor, Peking Union Medical College Hospital) — Sponsor-investigator
First posted
Aug 16, 2017
Start date
Dec 1, 2016
Primary completion
Dec 31, 2017
Completion
Dec 31, 2018 (estimated)
Last update
Feb 5, 2018

Study contacts

Lei Li, MD
Contact
lileigh@163.com
13911988831 ext. +86
Aijun Sun, MD
principal investigator · Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion