| CTRI Number |
CTRI/2025/10/095584 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the Effectiveness of Karpoor Ghrita ointment and Povidone-Iodine Ointment in Healing of Episiotomy Wound in New Mothers |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Karpoor Ghrita Ointment versus Povidone-Iodine Ointment in Management of Episiotomy Wounds: A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NIDHI BHALERAO |
| Designation |
PG SCHOLAR |
| Affiliation |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA |
| Address |
ROOM NO 9 DEPARTMENT OF PRASUTI TANTRA AND STRIROG MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9503007378 |
| Fax |
|
| Email |
drnidhibhalerao0603@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NIDHI BHALERAO |
| Designation |
PG SCHOLAR |
| Affiliation |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA |
| Address |
ROOM NO 9 DEPARTMENT OF PRASUTI TANTRA AND STRIROG MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9503007378 |
| Fax |
|
| Email |
drnidhibhalerao0603@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHILPA JAMDADE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA |
| Address |
ROOM NO 9 DEPARTMENT OF PRASUTI TANTRA AND STRIROG MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9769493806 |
| Fax |
|
| Email |
dr.shilpajamdade@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA |
|
|
Primary Sponsor
|
| Name |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA |
| Address |
Room No 9 Department of Prasuti Tantra and Strirog MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 NIDHI BHALERAO |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA |
ROOM NO 9 DEPARTMENT OF PRASUTI TANTRA AND STRIROG MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA
Wardha
MAHARASHTRA |
9503007378
drnidhibhalerao0603@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KARPOOR GHRITA OINTMENT , Reference: BHAISHJYARATNAVALI, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | POVIDONE IODINE OINTMENT | POVIDONE IODINE OINTMENT WILL BE GIVEN FOR LOCAL APPLICATION ON EPISIOTOMY WOUND FOR 07 DAYS ONCE A DAY ON 33 SUBJECTS |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
PRIMIPARA AND MULTIPARA |
|
| ExclusionCriteria |
| Details |
PATIENTS WITH LABOR COMPLICATIONS SUCH AS EXTENSIVE PERINEAL TEAR PPH PLACENTA RETENTION
SYSTEMIC DISORDERS INSTRUMENTAL VAGINAL DELIVERY
HIV HBSAG VDRL
3 AND 4 DEGREE PERINEAL TEAR
PRE EXISTING CONDITIONS PREGNANCY INDUCED ILLNESSES SUCH AS ANEMIA LEUKOCYTOSIS |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Comparative Efficacy of Karpoor Ghrita ointment versus Povidone Iodine Ointment in Management of Episiotomy Wounds |
0th day 3rd day 8th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Comparative Efficacy of Karpoor Ghrita ointment versus Povidone Iodine Ointment in Management of Episiotomy Wounds |
0th day 3rd day 8th day |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The volunteer will be inform about the study protocol. Willing participents will be randomly selected as per computer generated table. Clinical research format will bw prepared and validated. Prior to study approval will be taken from IEC,MGACHRC,SALOD(H),Wardha and CTRI Registration will be done. After selection each participents will be tested individually and selected according to selection criteria. They are divided into two groups the trial is Randomized open labelled standard controlled supriority clinical trail. It will include a 7 days treatment period and assessment during treatment on 0th day 3rd day 8th day and follow up on 8th day & 15th day. |