| CTRI Number |
CTRI/2025/04/086079 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| 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
|
Comparative Study on the Effectiveness of Gandhak Druti and Gandhak Druti Ointment in Healing Infected Wounds (Dushta Vrana)
|
|
Scientific Title of Study
|
A Comparative clinical study of Gandhak Druti and Gandhak Druti Ointment in the management of Dushta Vrana W.S.R to infected wounds |
| 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 Aditi Atul Shah |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Shalya Tantra Parul Institute of Ayurved and Research Parul
University,Vadodara -391760,Gujarat
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9404368606 |
| Fax |
|
| Email |
aditishah9404@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrakant Pawar |
| Designation |
Professor & HOD |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Shalya Tantra Parul Institute of Ayurved and Research Parul
University,Vadodara -391760,Gujarat
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9822711566 |
| Fax |
|
| Email |
drchandrakantpawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrakant Pawar |
| Designation |
Professor & HOD |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Shalya Tantra Parul Institute of Ayurved and Research Parul
University,Vadodara -391760,Gujarat
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9822711566 |
| Fax |
|
| Email |
drchandrakantpawar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of
ayurved and research, Parul University,P.O Limda,Vadodara, Gujarat -391760, India |
|
|
Primary Sponsor
|
| Name |
Dr.Aditi atul shah |
| Address |
Department of Shalya Tantra, Parul Institute of Ayurved and
Research, Parul University, Vadodara, Gujarat -391760, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Aditi Atul Shah |
Khemdas Hospital |
OPD No. 2 Ground Floor Department of Shalya Tantra Parul Institute of Ayurved and Research ,Parul
University,Vadodara -391760,Gujarat
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT |
09404368606
aditishah9404@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIAR-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Gandhak Druti Ointment, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -gandhaka druti ointment is modified form of gandhaka druti is used in treating dushta vrana | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gandhaka Druti, Reference: Rasayogasagar, Route: Topical, Dosage Form: Dravaka, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -gandhaka druti is classical medicine used for treating dusta vrana in comapare with gandhaka druti ointment |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Dushta Vrana
Patients who fulfilling diagnostic criteria
Depth- Superficial to Full thickness wound
Area of wound - maximum length more tha 10cm and width 10cm
shape- all shapes |
|
| ExclusionCriteria |
| Details |
If Patient is having Allergy to sulphur
Patients with systemic infections
Patients with Gangrene
Burns wounds and wounds with malignance
Patients with Uncontrolled Diabetes and tubercular ulcer
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Pain, Itching, and Burning Sensation and wound healing upto granulation of tissue will be assessed according to scale |
assessment should be done every weekly i.e 7th Day, 14th Day, 21th Day and 28th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in skin color, odour, exudation level, size of wound, granulation and slough of wound |
assessment should be done every weekly i.e 7th Day, 14th Day, 21th Day and 28th Day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
23/06/2025 |
| 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 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
|
The management of Dushta Vrana (infected wounds) is a significant challenge in surgery, requiring wound cleansing, removal of necrotic tissue, and microbial control to ensure proper healing. While modern medicine offers many wound care options, Ayurvedic interventions are less explored. Ayurveda emphasizes Vrana Shodhana (wound cleansing) as detailed in texts like Sushruta Samhita, and Gandhak Druti—a herbo-mineral preparation—is noted for its wound healing potential. Previous studies suggest Gandhak Druti’s promising role, but direct clinical comparisons are limited. This study aims to evaluate and compare the effectiveness of Gandhak Druti and Gandhak Druti ointment in managing Dushta Vrana. Sixty patients will be divided into two groups and treated for one month, with weekly assessments based on subjective (pain, itching, burning) and objective (odor, color, exudate, wound size, granulation, slough) parameters. Drug preparation methods, diagnostic criteria, inclusion/exclusion guidelines, and thorough clinical monitoring have been outlined. The study aims to determine which form—liquid or ointment—is more effective in promoting healing and improving patient outcomes while contributing to affordable and accessible wound care solutions. |