| CTRI Number |
CTRI/2025/06/089704 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to know the effect of Sarjikadya Ghrita ointment in the treatment of chronic wound/ulcers. |
|
Scientific Title of Study
|
A Comparative Clinical study to evaluate the Shodhana and Ropana effect of Sarjikadya Ghrita Ointment over Povidone Iodine Ointment in the Management of Dushta Vrana (Chronic Ulcers). |
| 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 Chinmayee Sanjay Chamat |
| Designation |
PG Scholar |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
| Address |
Room No 16, Department of post graduation studies in Shalya tantra, Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, koppal, Karnataka, INDIA, PIN-583231
Koppal KARNATAKA 583231 India |
| Phone |
7795832714 |
| Fax |
|
| Email |
stafinacorrens1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mahantesh M salimath |
| Designation |
Professor |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
| Address |
Room No 16, Department of post graduation studies in Shalya tantra, Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, koppal, Karnataka, INDIA, PIN-583231
Koppal KARNATAKA 583231 India |
| Phone |
9845010950 |
| Fax |
|
| Email |
dr_mahantesh@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Chinmayee Sanjay Chamat |
| Designation |
PG Scholar |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
| Address |
Room No 16, Department of post graduation studies in Shalya tantra, Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, koppal, Karnataka, INDIA, PIN-583231
Koppal KARNATAKA 583231 India |
| Phone |
7795832714 |
| Fax |
|
| Email |
stafinacorrens1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College post graduate studies and research centre |
|
|
Primary Sponsor
|
| Name |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
| Address |
Room No 16, Department of post graduation studies in Shalya tantra, Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Gavimath, koppal, Karnataka, INDIA, PIN-583231 |
| 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 Chinmayee Sanjay Chamat |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
Room No 16, Department of post graduation studies in Shalya tantra Koppal KARNATAKA |
07795832714
stafinacorrens1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L98||Other disorders of skin and subcutaneous tissue, not elsewhere classified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SARJIKADYA GHRITA OINTMENT, Reference: YOGARATNAKARA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -TOPICAL APPLICATION OF SARJIKADYA GHRITA OINTMENT OVER DUSHTA VRANA | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone Iodine Ointment | Povidone Iodine Ointment in the dosage of 2 mg is applied topically over the wound once a day for the duration of 28 days. |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Wound size upto 5x5x1 cm
wound chronicity upto 2 yrs |
|
| ExclusionCriteria |
| Details |
ischaemic ulcer
uncontrolled T2 Diabetes mellitus and hypertension
HIV HCV and HbsAg positive patients
patients with bleeding disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of objective parameters-
Discharge
Size
Depth
Granulation Tissue |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of-
pain
|
Total Study duration per patient-60 days
Treatment Duration-28 days
Follow up day- 45th and 60th day
Assessment done on-
1st day(Before Treatment)
14th day(During Treatment)
28th day(During Treatment)
45th day (After Treatment)
60th day(After Treatment) |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/07/2025 |
| 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="0" Months="6" Days="10" |
|
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
|
The word “Vrana” denotes “Vrana Gatra Vichurnane[1]” which means tissue disruption. Vrana cannot heal by itself when it is present in Dushta avastha hence Vrana Shodhana is done followed by Vrana ropana for healing of Dushta Vrana. . It can be clinically correlated to chronic ulcers based on lakshanas mentioned by Acharya. An ulcer is defined as break in the continuity of the covering epithelium - skin or mucous membrane. It may either follow molecular death of the surface epithelium or its traumatic removal [2] and is usually seen affecting human beings at any age. In India a study conducted in 2018 estimated a prevalence rate of Chronic wounds at 4.5% per 1000 population [3]. In contemporary science procedures like Dressings, Topical Antimicrobials, Enzymes (Papain-Urea combinations) ,along with some advanced modalities like Negative pressure wound Therapy , Hyperbaric oxygen therapy, Acellular matrix tissues ,Bio-engineered Allogenic cellular therapies, Stem cell therapies , Hyalomatrix are used[4] but these interventions are not cost effective and not easily available. According to estimation from the World Health Organization, 80% of the world’s population relies on traditional medicines for their Primary Healthcare [5]. The classical treatments for wound healing which are mentioned in Sushrut Samhita such as Shashti-Upakrama can help in treating Dushta Vrana. Application of Ghrita is one such form which is mentioned in Shashti Upakrama [6]. Sarjikadya Ghrita is Vrana Ropaka, Krimi-kanduhara and Savarnikarana. It is mentioned in Yoga Ratnakar. It contains drugs such as Yava Kshara and Sarjika Kshara which does Chedana, Bhedana and lekhana of Vrana and their Tridoshahara guna helps to remove unhealthy granulation tissue from Dushta vrana. Tankana, Sasyaka and Kampillaka have Antimicrobial property. Harenuka is known for wound healing properties. Sweta khadira present in formulation is known for its Kandughna and Savarnikarana karma. This formulation is told in the form of Ghrita in which Go-Ghrita is used to reduce pain, inflammation and burning sensation in Vrana. For the feasibility of application this Ghrita is further modified into ointment form to facilitate easy application .The ingredients present in this formulation are easily available and cost effective. Hence an attempt is made to evaluate the effect of Sarjikadya Ghrita in ointment form over Dushta Vrana. |