| CTRI Number |
CTRI/2026/02/105029 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Marham e Katan for healing wounds after childbirth |
|
Scientific Title of Study
|
Efficacy of Unani formulation Marham e Katan in comparison with povidone iodine 5 percent ointment on perineal wounds in postpartum women |
| 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 Yasmeen Fatima |
| Designation |
Pg scholar |
| Affiliation |
Government Nizamia Tibbi College |
| Address |
ANC OPD room no 4
Maternity ward 4
PG Department of Gynaecology and Obstetrics
Government Nizamia Tibbi College and General hospital
Charminar Hyderabad TG
Hyderabad
TELANGANA
500002
India |
| Phone |
7032964614 |
| Fax |
|
| Email |
imrafatima572@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. A. Suhasini |
| Designation |
Professor |
| Affiliation |
Government Nizamia Tibbi College |
| Address |
Government Nizamia Tibbi College Charminar Hyderabad TG
Charminar Hyderabad TG
Hyderabad
TELANGANA
500002
India |
| Phone |
9949586899 |
| Fax |
|
| Email |
drasuhasini12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yasmeen Fatima |
| Designation |
Pg scholar |
| Affiliation |
Government Nizamia Tibbi College |
| Address |
ANC OPD room 4
Maternity ward 4
PG Department of Gynaecology and Obstetrics
Government Nizamia Tibbi College and General hospital
Charminar Hyderabad TG
Hyderabad
TELANGANA
500002
India |
| Phone |
7032964614 |
| Fax |
|
| Email |
imrafatima572@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College and General Hospital Charminar Hyderabad Telangana 500002 India |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College |
| Address |
Charminar Hyderabad Telangana 500002 |
| Type of Sponsor |
Government medical college |
|
|
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 Yasmeen Fatima |
Government Nizamia Tibbi College |
ANC OPD room no.4 and maternity ward 4
Government Nizamia Tibbi College and General Hoapital Hyderabad Telangana 500002
Hyderabad
TELANGANA |
7032964614
imrafatima572@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O701||Second degree perineal lacerationduring delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Marham e Katan |
Under aseptic precautions and after cleaning the perineal wound marham e katan will be applied twice a day as required depending on the wound size for a period of 10 days |
| Comparator Agent |
Standard Povidone iodine five percent ointment |
Under aseptic precautions and after cleaning the perineal wound standard povidone iodine five percent ointment will be applied twice a day as required depending on the wound size for a period of 10 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Female |
| Details |
Primiparous or multiparous postpartum women with normal vaginal delivery
Episiotomy wound
First and second degree perineal tears according to revised sultans criteria |
|
| ExclusionCriteria |
| Details |
Diagnosed cases of diabetes mellitus and bleeding disorders
Women with sexually transmitted diseases
Women with third and fourth degree perineal tears according to revised sultans criteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound healing assessed by REEDA (Redness, Edema, Ecchymosis, Drainage, Approximation) Scale |
baseline day 0
weekly twice for 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain relief assessed by Visual Analog Scale |
baseline day 0
weekly twice for 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
12/03/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Title : Efficacy of Unani formulation Marham e katan in comparison with Povidone iodine 5 % ointment on perineal wounds in postpartum women.
Aim : To evaluate the efficacy of Unani formulation Marham e Katan on perineal wounds in postpartum women.
Inclusion criteria : Primiparous /multiparous postpartum women with normal vaginal delivery. Episiotomy wound and perineal tears (1 and 2 degree according to revised Sultan’s criteria). Women with normal bleeding and clotting time.
Exclusion criteria : Diagnosed cases of diabetes mellitus and bleeding disorders. Women with sexually transmitted infections. Women with 3 and 4 degree perineal tears. Sample size : 60 (Group A 30 participants , Group B 30 participants)
Intervention : Group A (Marham e Katan) Group B(Standard povidone iodine 5% ointment)
Group A participants will be treated under aseptic precautions, after cleaning the episiotomy wound /perineal tear Marham e katan will be applied as required, twice a day for 10 days Group B participants will be treated under aseptic precautions, after cleaning the episiotomy wound/perineal tear standard povidone iodine 5 % ointment will be applied as required , twice a day for 10 days
Outcome: Primary outcome is wound healing assessed by REEDA scale Secondary outcome is pain relief assessed by VAS scale
|