Health Condition 1: N72- Inflammatory disease of cervix uteri
Conditions
Interventions
Intervention1: Placentrex Inj 2 mL and Tab AZ3 Azithromycin 1 gm: Placentrex Inj 2 mL IM for 14 days and Tab AZ3 Azithromycin 1 gm, to be taken orally once daily for 7 days after meals
Control Interve
Sponsors
Albert David Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female subjects in the age group of 18 to 45 years with lower abdominal or pelvic pain and cervical motion or pelvic tenderness, adnexal tenderness based on historical USG. 2. Patients diagnosed to have Recurrent PID. 3. Patients with primary or secondary infertility with diagnosis of PID. 4. Patients with persistent PID despite antibiotic treatment within past 6 weeks. 5. Willing to receive intramuscular (IM) injections for 14 days
Exclusion criteria
Exclusion criteria: 1. Postmenopausal women 2. Subjects who were pregnant or breastfeeding. 3. Subjects on active treatment or with evidence of active tuberculosis/STD. 4. Subjects with known case of endometriosis 5. Any hepatic or renal impairment 6. Participation in any other clinical trial in the past one month. 7. Patients unlikely to comply with trial protocol. 8. Any other debilitating systemic condition in the opinion of the Investigator that would deem the subject unfit to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and proportion of subjects classified as excellent, good and poor on the Clinical Global Impression Scale defined as follows at 2 weeks and 12 weeks and compared between the two arms: 1 Excellent: Resolution of the majority of presenting symptoms. 2 Good: Majority of presenting symptoms unresolved but adequately controlled. 3 Poor: Minimal improvement or worsening in presenting symptomsTimepoint: Visit 1 : Day 0 Screening and Randomization Visit 2 : Day 7 Visit 3 : Day 14 Visit 4 : Day 84 Visit 5 : Day 365 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number and proportion of subjects reporting a relapse or recurrence of symptoms of PID at end of 12 weeks and in the one year follow up period and compared between the two arms 2. Number and proportion of subjects with a positive pregnancy in the one year follow up period and compared between the two armsTimepoint: Visit 1 : Day 0 Screening and Randomization Visit 2 : Day 7 Visit 3 : Day 14 Visit 4 : Day 84 Visit 5 : Day 365 | — |
Countries
India
Contacts
Public ContactDr Subhasri Bandyopadhyay
Albert David Limited
Outcome results
None listed