| CTRI Number |
CTRI/2026/02/105077 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| 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
|
Shalmali glue for Cut Wounds |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE
THE EFFICACY OF SHALMALI GLUE IN THE MANAGEMENT OF
INCISED WOUND.” |
| Trial Acronym |
SAGE Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SNEH R RATHOD |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul institute of Ayurved |
| Address |
Parul Institute of Ayurved, Parul university, Post. Ishwarpura - Limda, Taluka. Waghodia, Dist. Vadodara, GJ SH 158, Limda, Gujarat
Parul Institute of Ayurved, Parul university, Post. Ishwarpura - Limda, Taluka. Waghodia, Dist. Vadodara, GJ SH 158, Limda, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9099620104 |
| Fax |
|
| Email |
rathodsneh2898@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Toshikhane |
| Designation |
Professor and HOI AND DEAN |
| Affiliation |
Parul institute of Ayurved |
| Address |
Deparment of PG and PhD studies in Shalya Tantra, Parul Institute of
Ayurved, Parul University, Post Limda, Waghodia, Gujarat 391760
Deparment of PG and PhD studies in Shalya Tantra, Parul Institute of
Ayurved, Parul University, Post Limda, Waghodia, Gujarat 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
hemant.toshikhane@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish Daga |
| Designation |
Associated Professor and Head of Department |
| Affiliation |
Parul institute of Ayurved |
| Address |
Room No 403 Deparment of Shalya Tantra, Parul Institute of
Ayurved, Parul University, Post Limda, Waghodia, Gujarat 391760
Room No 403 Deparment of Shalya Tantra, Parul Institute of
Ayurved, Parul University, Post Limda, Waghodia, Gujarat 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9413662079 |
| Fax |
|
| Email |
harish.daga26839@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| PARUL AYURVED HOSPITAL Parul University Taluka Waghodia District Vadodara
State Gujarat India Pincode-391760
|
|
|
Primary Sponsor
|
| Name |
parul institute of ayurved |
| Address |
Parul University, Post Limda, Waghodia, Gujarat 391760 Vadodara
GUJARAT 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 SNEH RATHOD |
Parul Ayurved of Hospital |
Shalya OPD No 106 Parul
Ayurved Hospital, Parul
University, Post Limda,
Waghodia, Gujarat 391760
Vadodara
GUJARAT |
9099620104
rathodsneh2898@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE, PARUL INSTITUTE OF AYURVED |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T148||Other injury of unspecified body region. 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: shalmali glue, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | 2-octyl cyanoacrylate | Route: Topical,Dose: 5(g), Frequency: OD,Duration : 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with giving informed written consent.
Patient aged between 15 to 60 years.
Patients having incised wound of maximum length 5 cm and depth facia.
Patients having maximum 6 hours of duration of Vrana.
Patients without any complications. |
|
| ExclusionCriteria |
| Details |
Patients suffering from Dustavrana (non healing wounds)
Patients with infection and malignant wounds will be excluded from the study.
Patients having deeper wound tearing muscle beneath.
Patients having profuse bleeding due to injury.
Patients having major complications like diabetes mellitus, varicose veins.
HIV, HBsAg , VDRL Positive patient. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in wound healing assessed using wound assessment parameters (Redness, Edema, Ecchymosis, Discharge and Approximation score).
|
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome
Reduction in pain assessed by Visual Analogue Scale (VAS). |
DAY 3, DAY 5, DAY 7 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/03/2026 |
| 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
|
This study is a randomized, open-label, comparative clinical trial designed to evaluate the efficacy and safety of Shalmali glue (Bombax ceiba gum) in the management of incised wounds. A total of 40 patients aged 15–60 years with fresh incised wounds (within 6 hours of injury) will be randomly allocated into two groups. Group A will receive topical application of Shalmali glue, and Group B will receive Dermabond glue as an active control.Wound healing will be assessed using objective parameters including redness, edema, ecchymosis, discharge, and wound approximation, along with pain assessment using the Visual Analogue Scale (VAS). Follow-up will be conducted on Day 3, Day 5, and Day 7. The study aims to determine whether Shalmali glue can serve as a safe and effective alternative to Dermabond for wound closure. |