Health Condition 1: N739- Female pelvic inflammatory disease, unspecified
Conditions
Interventions
Intervention1: 2.5xPlacentrex Injection (0.1 gm of placentral extract in 2 ml): OD intramuscular dose of 2 ml for 10 days with standard of care treatment of Azithromycin 1 g tablet for 7 days.
Interve
Sponsors
Albert David India Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women of childbearing age group of 20 to 40 years. 2. Patients had a history of PID (not more than 12 months from the screening) with pain in lower abdomen, dysmenorrhoea, dyspareunia or vaginal discharge. 3. Patients came with complaints of lower abdominal or pelvic pain and cervical motion, pelvic tenderness, or adnexal tenderness and were diagnosed with recurrent (more than 2 episodes) PID. 4. Patients came with primary or secondary infertility with PID. 5. Patients had persisted PID despite antibiotic treatment within 6 weeks preceding enrolment. 6. Patients are willing to receive intramuscular (IM) injections for at least 14 days. 7. Patients who are willing to provide written informed consent prior to the performance of any study-specific procedures. 8. Patients with a negative urine/serum pregnancy test at the time of screening. 9. Patients who are willing to use effective methods of contraceptives during the study period. 10. Patients who are willing and able to comply with all study assessments and adhere to the protocol schedule.
Exclusion criteria
Exclusion criteria: 1. Postmenopausal women. 2. Patients on active treatment or with evidence of active tuberculosis/sexually transmitted disease (STD). 3. History of more than 3 episodes of documented PID/bacterial STD. 4. Patients with known endometriosis. 5. Pregnant or lactating women. 6. History or presence of ovarian cyst, malignancy. 7. Patients who are on the medication are likely to interfere with the study. 8. Patients who are unwilling or unable to give written informed consent. 9. Patients involved in clinical trials and taken investigational drugs within 30 days of enrolment. 10. Any severe, acute or chronic medical condition that may affect the patients ability to participate in the study, may lead to unacceptable security risks and non-compliance with protocol procedures or may interfere with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with excellent, good, and poor responses based on the Clinical Global Impression Scale (CGI) at 2 and 12 weeks.Timepoint: Baseline through week-2 and week-12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse/recurrence rate of PID symptoms.Timepoint: at 12 weeks. | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
MBBS, MD, DNB
Outcome results
None listed