| CTRI Number |
CTRI/2025/12/099082 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Unani ointment on perineal Wound in Postpartum Women. |
|
Scientific Title of Study
|
Efficacy of Roghan-e-Raal Versus Povidone-Iodine Ointment in Perineal Wound Healing in Postpartum Women: A Randomized Standard Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Farhat Quamar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Room No. 29, OPD, Amraze Niswan Kottigeplaya, Magadi Main Road,
Bangalore
KARNATAKA
560091
India |
| Phone |
7766085975 |
| Fax |
|
| Email |
farhatquamar08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Farhat Quamar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Room No. 29, OPD, Amraze Niswan Kottigeplaya, Magadi Main Road,
Bangalore
KARNATAKA
560091
India |
| Phone |
7766085975 |
| Fax |
|
| Email |
farhatquamar08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arshiya Sultana |
| Designation |
Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Room No. 29, OPD, Amraze Niswan Kottigeplaya, Magadi Main Road,
Bangalore
KARNATAKA
560091
India |
| Phone |
09740915911 |
| Fax |
|
| Email |
drarshiya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru-560091, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
National Institute Of Unani Medicine |
| Address |
Kottigepalya, Magadi Main Road, Bengaluru-560091, Karnataka |
| 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 Arshiya Sultana |
National Institute of Unani Medicine |
Room No. 29, OPD, Amraze Niswan Kottigeplaya, Magadi Main Road,
Bangalore
KARNATAKA |
09740915911
drarshiya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Unani Medicine, Institutional Ethics committee for biomedical research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O709||Perineal laceration during delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
povidine iodine 5% |
The ointment will be applied externally twice daily for a duration of 10 days. The first application will be administered 4 hours after childbirth, during which participants will be instructed on how to apply the ointment themselves. The ointment will be applied to the perineal wound (suture line) after gently washing with warm water and drying the perineal area. After application, the area will be covered with a clean sanitary pad within 1–2 minutes. Participants will be advised to repeat this procedure every 12 hours until the 10th day postpartum. In the control group, povidone-iodine ointment will be used in the same manner. |
| Intervention |
Roghan e Raal |
Roghan e Raal will be applied externally twice daily for a duration of 10 days. The first application will be administered 4 hours after childbirth, during which participants will be instructed on how to apply the ointment themselves. The ointment will be applied to the perineal wound (suture line) after gently washing with warm water and drying the perineal area. After application, the area will be covered with a clean sanitary pad within 1–2 minutes. Participants will be advised to repeat this procedure every 12 hours until the 10th day postpartum. In the control group, povidone-iodine ointment will be used in the same manner. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Primiparous or multiparous women
2. Live singleton pregnancy with 37-42 weeks of gestation with cephalic presentation.
3. Episiotomy or 1st degree or 2nd degree perineal tear.
|
|
| ExclusionCriteria |
| Details |
1. Sensitivity to Roghan-e-Raal.
2. History of chronic systemic diseases hindering wound healing (e.g., coagulation disorders, diabetes, and severe anaemia (Hb less than 7 gm/dl).
3. Postpartum women with perineal hematoma, third or fourth degree perineal tear
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REEDA score for wound healing |
4hrs (baseline), 24hrs, 48hrs, and 10-14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VAS score for pain assessment and number of analgesics will be assessed.
Patients Global Assessment of Tolerability to Therapy (PGATT) and Patient Global Assessment of Response to Therapy (PGART) |
4hrs (baseline), 24hrs, 48hrs, and 10-14 Days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
10/01/2026 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Postpartum
women with episiotomy or 1st or 2nd degree perineal tear will be selected (n=64), and written informed consent will be obtained before the study. The initial assessment of REEDA and VAS will be
conducted immediately before the intervention (four hours after delivery).
After intervention, REEDA and VAS assessment will be performed 24 hours, 48
hours, and 10-14 Days after episiotomy/perineal tear. In the test group,
externally Roghan-e-Raal, 2g twice daily for 10 days, will be applied to
the perineal wound. In the control group, povidone-iodine (5%) will be applied 2g twice a day for 10 days. All of them will receive an injection of
Ceftriaxone 1
g stat in the intrapartum period. In the postnatal period, analgesic (diclofenac
50 mg) will be given SOS for 5 days as rescue medicine. Participants
fulfilling the inclusion criteria mentioned above will be given the information sheet, which has
details regarding the nature of the study
and the drugs to be used. Participants will be given enough time to go through
the study details mentioned in the information sheet. They will be allowed to ask any questions, and if they agree to participate in the study, they
will be asked to sign the informed consent
form. The
appropriate tests will be applied to analyse the data. Descriptive statistical
analysis will be used in the study. Results on continuous measurements will be
presented in mean (SD), and results on the categorical measurements will be
presented in number (%) with 5% level of significance and 95% confidence Interval.
|