| CTRI Number |
CTRI/2024/12/077552 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to evaluate the safety and effectiveness of Human Placental Extract injection in patients with Recurrent Pelvic Inflammatory Disease. |
|
Scientific Title of Study
|
An open-label, single-center, investigator-initiated, randomized, pilot study to determine the efficacy and safety of 2.5X Placentrex Placentrex (Human Placental Extract) Injections
in Recurrent Pelvic Inflammatory Disease (PID). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-PLA-PID-02 Version 1.0 dated 17 Jul 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pathak Urvashi Mahenndrakumar |
| Designation |
Associate Professor |
| Affiliation |
MBBS, MD, DNB |
| Address |
Room no. 1, OBG Department, Rajalakshmi Hospital & Research Center,Lakshmipura Main Road, Lake, opp. Lakshmipura, Lakshmipura, Vidyaranyapura, Bengaluru, Karnataka 560097
Bangalore
KARNATAKA
560097
India |
| Phone |
9448696741 |
| Fax |
|
| Email |
urvashibhatara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pathak Urvashi Mahenndrakumar |
| Designation |
Associate Professor |
| Affiliation |
MBBS, MD, DNB |
| Address |
Room no. 1, OBG Department, Rajalakshmi Hospital & Research Center,Lakshmipura Main Road, Lake, opp. Lakshmipura, Lakshmipura, Vidyaranyapura, Bengaluru, Karnataka 560097
Bangalore
KARNATAKA
560097
India |
| Phone |
9448696741 |
| Fax |
|
| Email |
urvashibhatara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Kumar |
| Designation |
CEO |
| Affiliation |
CliniExperts Research Services Pvt. Ltd. |
| Address |
Unit No. 324-325, City Centre Mall, Plot No. 5, Pocket 8, Block B, Sector 12 Dwarka, Dwarka, New Delhi, Delhi, 110075, India
New Delhi
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
|
Source of Monetary or Material Support
|
| Albert David India Pvt. Ltd.
D Block, 3rd Floor, Gillander
House, Netaji Subhas Road,
Kolkata - 700001, India. |
|
|
Primary Sponsor
|
| Name |
Albert David India Pvt. Ltd. |
| Address |
D Block, 3rd Floor, Gillander House, Netaji Subhas Road, Kolkata - 700001, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pathak Urvashi Mahenndrakumar |
Rajalakshmi Hospital & Research Center |
Room no. 1, OBG Department, Rajalakshmi Hospital & Research Center, Lakshmipura Main Road, Lake, opp. Lakshmipura, Lakshmipura, Vidyaranyapura, Bengaluru, Karnataka 560097, India
Bangalore
KARNATAKA |
9448696741
urvashibhatara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N739||Female pelvic inflammatory disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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. |
| Intervention |
2.5xPlacentrex Injection (0.1 gm of placentral extract in 2 ml) |
OD intramuscular dose of 2 ml for 7 days with standard of care treatment of Azithromycin 1 g tablet for 7 days. |
| Comparator Agent |
Placentrex Injection (0.1 gm of placentral extract in 2 ml) |
OD intramuscular dose of 2 ml for 14 days with standard of care treatment of Azithromycin 1 g tablet for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients with excellent, good, and poor responses based on the Clinical Global Impression Scale (CGI) at 2 and 12 weeks. |
Baseline through week-2 and week-12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relapse/recurrence rate of PID symptoms. |
at 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This open-label, single-center, investigator-initiated pilot study aims to evaluate the efficacy and safety of 2.5X Placentrex (Human Placental Extract) Injections in treating Recurrent Pelvic Inflammatory Disease (PID). PID is an infection of the upper reproductive organs, which can lead to severe complications if untreated. The study compares the non-inferiority of 2.5X Placentrex Injections (0.1gm of placental extract in 2 ml) for 10 and 7 days with the standard 14-day Placentrex Injection treatment.The study involves 45 participants, divided into three groups, each receiving different treatment durations. The primary objective is to assess the efficacy of the investigational product, while the secondary objective focuses on safety. Participants will undergo a 12-week study period, including screening, treatment, and follow-up. Efficacy will be measured using the Clinical Global Impression Scale, and safety will be monitored through adverse event reporting and physical examinations. |