| CTRI Number |
CTRI/2025/11/097693 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Turmeric gel for faster healing of post delivery incision |
|
Scientific Title of Study
|
A Clinical Study on the Evaluation of Haridra (Curcuma longa Linn.) Loaded Niosomal Gel for Episiotomy Wound Healing with Special Reference to Vrana Ropana. |
| 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 Rubab Chaudhary |
| Designation |
PG Scholar Stree roga prasuti Tantra |
| Affiliation |
Kunwar shekhar vijendra ayurved medical college and research centre, Shobhit university ,Gangoh |
| Address |
Department of pg studies in stree roga prasuti tantra kunwar shekhar vijendra ayurved medical college and research centre shobhit university gangoh,
saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9818602808 |
| Fax |
|
| Email |
rubabchaudhary86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Jayalekshmi |
| Designation |
Professor |
| Affiliation |
Kunwar shekhar vijendra ayurved medical college and research centre, Shobhit university ,Gangoh |
| Address |
OPD NO 3 Department of pg studies in stree roga prasuti tantra kunwar shekhar vijendra ayurved medical college and research centre shobhit university gangoh,
saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
8838460272 |
| Fax |
|
| Email |
dr.lekshmy83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Jayalekshmi |
| Designation |
Professor |
| Affiliation |
Kunwar shekhar vijendra ayurved medical college and research centre, Shobhit university ,Gangoh |
| Address |
OPD NO 3 Department of pg studies in stree roga prasuti tantra kunwar shekhar vijendra ayurved medical college and research centre shobhit university gangoh,
saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
8838460272 |
| Fax |
|
| Email |
dr.lekshmy83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre ,Shobhit University , Gangoh , Saharanpur , Uttar Pradesh, 247341, India |
|
|
Primary Sponsor
|
| Name |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre |
| Address |
OPD NO 3 Department of PG Studies in Prasuti Tantra Stree Roga Kunwar Shekhar Ayurved medical college and research centre , Shobhit University, Gangoh , Saharanpur, 247341, India |
| 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 Rubab Chaudhary |
Kunwar Shekhar Vijendra Ayurved Medical College and research Centre |
Department of pg studies in stree roga prasuti tantra kunwar shekhar vijendra ayurved medical college and research centre shobhit university gangoh,
saharanpur
Saharanpur
UTTAR PRADESH |
09818602808
rubabchaudhary86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, kunwar shekhar vijendra Ayurved Medical College and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O860||Infection of obstetric surgical wound. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Haridra, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
.women age between 18 to 35 who have undergoes normal vaginal delivery with mediolateral episiotomy
.primiparous women
.Healthy term pregnancy
.REEDA score equivalent or less than 4
.who can attain hospital for a regular follow up
.patients who give written informed consent for the clinical trial
.singleton vaginal delivery |
|
| ExclusionCriteria |
| Details |
.women of age less than 18 years and more than 35 years
.episiotomy wound infection already present at day 1
.women with intrumental deliveries (foreceps or vaccum assisted)
.multiparous women
.known case of diabetes mellitus,hypertension , or immunocompromised status
.known allergy ,hypersensitivity
.post partum complications |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to assess the rate and quality of wound healing using Haridra loaded niosomal gel
.to evaluate changes in redness,oedema ,ecchymosis, discharge ,approximation score, and pain (VAS scale) during the healing process |
Day 1(baseline) ,day 7,day 15 and with additional observation at day 21 and day 30 to evaluate sustained healing and late occuring effect |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the antimicrobial effect of Haridra loaded niosomal gel |
Day 1 (baseline), day 7, day 15 and with additional observation at day 21, and day 30 to evaluate sustained healing and late occuring effect |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/11/2025 |
| 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="1"
Months="6"
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
|
This study is single arm single centre pilot study to evaluate the efficacy of Haridra (Curcuma longa Linn) Loaded Niosomal Gel for 18 months in 30 patients for Episiotomy wound healing with special refrence to Vrana Ropana The primary outcomes measures will be to assess the rate and quality of wound healing using Haridra loaded niosomal gel and to evaluate changes in Redness, Ecchymosis, Discharge , Approximatiion score, and pain (VAS scale) during the healing process The secondary outcomes measures will be based on to assess the antimicrobial effects of Haridra loaded Niosomal gel |