Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-21

Study Completion Date

2022-03-11

Brief Summary

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Randomized, double blind and positive-controlled clinical trial to assess the efficacy and safety of Fuke Qianjin Capsule compared to Doxycycline Hyclate Tablet in patients with mild to medium PID and its sequalae.

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Detailed Description

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Study participants will be randomly assigned to Test or Control group and the following schedule will be followed

Test group: metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days.

Control group: metronidazole tablets + doxycycline hyclate tablets, are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.

Fuke Qianjin Capsules and their simulants are taken as 2 capsules at a time, 3 times a day, orally after breakfast, lunch and dinner, respectively; Metronidazole Tablets are taken as 2 tablets (0.2 g/tablet) at a time, twice a day, at the same time as breakfast and dinner, respectively; Doxycycline Hyclate Tablet and their simulants are taken as 1 tablet (0.1 g/tablet, Doxycycline Hyclate Tablet calculated as C22H24N2O8) at a time, twice a day, at the same time as breakfast and dinner, respectively.

Scoring pain, symptoms, local signs, routine leucorrhea, cervical secretions, gynaecological B-ultrasound will be examined before the enrollment and after study completion.

Conditions

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Pelvic Inflammatory Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double-blind, positive control

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Participant and investigator both are blind

Study Groups

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Fuke Qianjin capsule

Metronidazole tablets + Doxycycline Hyclate tablets simulant are consecutively taken for 14 days, while the Fuke Qianjin capsule is consecutively taken for 28 days.

Fuke Qianjin Capsules are taken as 2 capsules at a time, 3 times a day, orally after breakfast, lunch, and dinner, respectively; Metronidazole Tablets are taken as 2 tablets (0.2 g/tablet) at a time, twice a day, at the same time as breakfast and dinner, respectively; Doxycycline Hyclate Tablet simulants are taken as 1 tablet (0.1 g/tablet, Doxycycline Hyclate Tablet calculated as C22H24N2O8) at a time, twice a day, at the same time as breakfast and dinner, respectively.

Group Type EXPERIMENTAL

Control Group

Intervention Type DRUG

metronidazole tablets + doxycycline hyclate tablets, are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.

Metronidazole tablets + Doxycycline hyclate tablets

Metronidazole tablets + Doxycycline hyclate tablets are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.

Fuke Qianjin Capsules simulants are taken as 2 capsules at a time, 3 times a day, orally after breakfast, lunch and dinner, respectively; Metronidazole Tablets are taken as 2 tablets (0.2 g/tablet) at a time, twice a day, at the same time as breakfast and dinner, respectively; Doxycycline Hyclate Tablet simulants are taken as 1 tablet (0.1 g/tablet, Doxycycline Hyclate Tablet calculated as C22H24N2O8) at a time, twice a day, at the same time as breakfast and dinner, respectively.

Group Type ACTIVE_COMPARATOR

Test Group

Intervention Type DRUG

metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days.

Interventions

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Control Group

metronidazole tablets + doxycycline hyclate tablets, are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.

Intervention Type DRUG

Test Group

metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days.

Intervention Type DRUG

Other Intervention Names

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Traditional Chinese Medicine (TCM)

Eligibility Criteria

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Inclusion Criteria

* Female patients aged 18-55.
* History of sexual life.
* Consistent with the diagnosis of pelvic inflammatory disease.
* VAS score ≥4.
* Voluntarily participate in the clinical trial and signed the Informed Consent form obtained before any trial-related procedures are performed

Exclusion Criteria

* Patients with severe pelvic inflammatory disease, or patients with dizziness, vomiting, high fever; pelvic abscess; fallopian tube ovarian abscess, etc.
* Absence of uterus.
* Patients with gynaecological tumors (uterine fibroids \> 5 cm in diameter, submucosal fibroids), specific vaginitis, adenomyosis, endometriosis, pelvic venous stasis, tuberculous pelvic inflammatory disease, abnormal uterine bleeding, etc. confirmed by examination, and related symptoms caused by other diseases.
* Patients with serious primary diseases of the heart, liver, kidney, hematopoietic system and those who have an impact on clinical trial as judged by the investigator.
* Patients with neurological and psychiatric disorders and unable or unwilling to cooperate.
* Allergic (allergic to two or more substances) or allergic to the components of this medicine; Suspected or indeed history of allergy to tetracyclines.
* Pregnant and breastfeeding women.
* Treated with similar drugs in the past 2 weeks.
* Those who are participating in or have participated in other clinical trials in the past 3 months.
* Suspected or confirmed history of alcohol or drug abuse, or other lesions or conditions that may reduce the possibility or complicate enrolment according to the judgment of the investigator, such as frequent changes in work environment and unstable living environment, which may easily lead to loss of follow-up.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No