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

NCT04723069 | Completed Phase 2

• 1 other identifier: CRO-007-TCM-FKQJ -2020
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Inflammatory Disease

Keywords

Triditional Chinese Medicine; Pelvic Inflammatory Disease (PID); Doxycycline Hyclate; Metronidazole

Outcome Measures

Primary Outcomes (1)

• Improvement in Visual Analog Scale (VAS) for pain assessment

  Applying the Visual Analogue Scale (VAS) i.e. 0-10 Numeric Pain Intensity Scale on a 10 cm line segment the pain will be assessed as 0 is painless, 10 is extremely painful. Patients will mark in the corresponding position according to the degree of pain, and the researcher will give a specific score. The grading criteria of Pelvic pain with VAS score will be, normal: 0 cm; mild: 1-3 cm; moderate: 4-6 cm; severe: 7-10 cm.

  after 28 days of treatment

Secondary Outcomes (2)

• Assessment of changes in main clinical Symptom

  after 28 days of treatment

• gynaecological B-ultrasound

  after 28 days of treatment

Other Outcomes (3)

• Labaratory Examination

  at day 0, 14 and after 28 days of treatment

• Vital signs examination

  at day 0, 14 and after 28 days of treatment

• Electrocardiogram

  at day 0, 14 and after 28 days of treatment

Study Arms (2)

Fuke Qianjin capsule

EXPERIMENTAL

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.

Drug: Control Group

Metronidazole tablets + Doxycycline hyclate tablets

ACTIVE COMPARATOR

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.

Drug: Test Group

Interventions

Control Group DRUG

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

Also known as: Traditional Chinese Medicine (TCM)

Fuke Qianjin capsule

Test Group DRUG

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

Metronidazole tablets + Doxycycline hyclate tablets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Only females with Pelvic inflammatory Disease are Eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Karachi: lead
• Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, China: collaborator
• Center for bioequivalence studies and Clinical Research (CBSCR), ICCBS, University of Karachi: collaborator

Study Sites (1)

Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi

Karachi, 75270, Pakistan

Location

Related Publications (1)

• Shah MR, Khan SN, Fatima S, Yao L, Yuan H, Ullah S, Ainuddin J, Zeng C, Zheng Y, Sahar N, Anwar S, Zhu M, Ma C, Kumari K, Wang W, Liu R. A randomized, double-blind, positive-controlled, Phase-II clinical trial to evaluate efficacy and safety of Fuke Qianjin capsule in Pakistani patients with pelvic inflammatory disease. Front Pharmacol. 2024 Mar 22;15:1287321. doi: 10.3389/fphar.2024.1287321. eCollection 2024.

  PMID: 38584600 DERIVED

Related Links

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

MeSH Terms

Conditions

Pelvic Inflammatory Disease

Interventions

Control Groups; Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Pelvic Infection; Infections; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Professor Dr. Muhammad Raza Shah

  Center for bioequivalence studies and Clinical Research (CBSCR), ICCBS, University of Karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant and investigator both are blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized, double-blind, positive control

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 25, 2021
• Study Start: September 21, 2021
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)