| CTRI Number |
CTRI/2025/08/093258 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effectiveness of Two Ayurvedic Oils in Chronic Wound Healing |
|
Scientific Title of Study
|
A comparative clinical study of svarjikadya taila and jatiyadi taila in the management of dustavrana w.s.r to Chronic ulcer |
| 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 Hansraj Vinay Singh |
| Designation |
PG Scholar |
| Affiliation |
Ramakrishna Ayurvedic Medical College, Hospital and Research Centre |
| Address |
Department of Shalya Tantra in PG Studies,Ramakrishna Ayurvedic Medical College, Hospital and Research Centre.54/2,Ramagondanahalli,Yelhanka,Bangalore
Bangalore
KARNATAKA
560064
India |
| Phone |
9004126077 |
| Fax |
|
| Email |
hansrajsingh1225@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anumarlapudi Jayaram |
| Designation |
HOD and Professor |
| Affiliation |
Ramakrishna Ayurvedic Medical College, Hospital and Research Centre |
| Address |
Department of Shalya Tantra in PG Studies,Ramakrishna Ayurvedic Medical College, Hospital and Research Centre.54/2,Ramagondanahalli,Yelhanka,Bangalore
Bangalore
KARNATAKA
560064
India |
| Phone |
8147926918 |
| Fax |
|
| Email |
anumarlapudi_j@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anumarlapudi Jayaram |
| Designation |
HOD and Professor |
| Affiliation |
Ramakrishna Ayurvedic Medical College, Hospital and Research Centre |
| Address |
Department of Shalya Tantra in PG Studies,Ramakrishna Ayurvedic Medical College, Hospital and Research Centre.54/2,Ramagondanahalli,Yelhanka,Bangalore
KARNATAKA
560064
India |
| Phone |
8147926918 |
| Fax |
|
| Email |
anumarlapudi_j@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Ramakrishna Ayurvedic Medical College ,Hospital and Research Centre.54/2, Yelahanka, Ramagondanahalli, Bengaluru, Karnataka 560064 |
|
|
Primary Sponsor
|
| Name |
Dr Hansraj Vinay Singh |
| Address |
Department of Shalya Tantra in PG Studies,Ramakrishna Ayurvedic Medical College,Hospital and Research Centre.54/2,Ramagondanahalli,Yelhanka,Bangalore-560064 |
| 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 Hansraj Vinay Singh |
Ramakrishna Ayurvedic Medical College, Hospital and Research Centre |
Department of Shalya Tantra in PG Studies,Ramakrishna Ayurvedic Medical College, Hospital and Research Centre.54/2,Ramagondanahalli,Yelhanka,Bangalore
Bangalore
KARNATAKA |
9004126077
Hansrajsingh1225@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramakrishna Ayurvedic Medical College, Hospital and Research Centre Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L984||Non-pressure chronic ulcer of skin, 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: Svarjikadya Taila, Reference: Chakradatta by Dr Indradeva Tripathi, Acharya Ramnath Dvivedi, Dr Satyadeva Dube Nadi vrana Chikitsa 45th chapter 16th sloka Choukhamba Sanskrit Sansthan, Varanasi 1st edition 1991 , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatiyadi Taila, Reference: Sharangadhara: Sharangadhara Samhita, Revised by Brahmanand Tripathi, Publisher Choukhamba Journal of Biomedical and pharmaceutical science, vol 3 issue: 4 355-359 year: 2016 , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. The patients with irrespective of age, sex, religion and occupation will be included for the study. 2. Solitary Dusta vrana is taken for study. 3. Ulcer up to the extent of skin and muscle. 4. Person with Dusta Vrana size upto size 6 cm. 5. Patients with clinical features of Dusta Vrana with indication for Shodhana |
|
| ExclusionCriteria |
| Details |
1.Tubercular, ischemic, Neurogenic, Malignant ulcers. 2.Uncontrolled DM. 3.Patients suffering from signs of gangrene. 4.Patients with features of septicemia. 5.Patients suffering from HIV, HBsAG and Hepatitis. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound healing |
0th day,7th day,14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2025 |
| 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="20" |
|
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 is Postgraduate Academic clinical study to compare the efficacy of Svarjikadya taila and Jatiyadi taila in management of Dustavrana Patients fulfilling the inclusion criteria of either gender will be selected randomly based on the history, symptoms and clinical examination from OPD and IPD of Shalya Tantra dept, Ramakrishna Ayurvedic Medical College, Yelahanka.
After diagnosis, 40 cases of Chronic ulcer are selected a distributed randomly in two groups namely Group A and Group B with 20 cases each excluding dropouts.
• Group A: Taila application with Svarjikadya taila
• Group B: Taila application with Jatiyadi taila
Observations regarding the changes in the features of the group will be made before and after the treatment.
The results were analyzed based on the proforma prepared for study.
|