| CTRI Number |
CTRI/2025/03/082338 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| 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
|
Comparing Anubhoota Yoga and Jatyadi Taila for Healing Dushta Vrana Chronic Wounds in Patients. |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Anubhoota Yoga and Jatyadi Taila in the Management of Dushta Vrana |
| 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 Sailash M |
| Designation |
Postgraduate Scholar |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital Hubballi |
| Address |
Department of Postgraduate Studies in Shalya Tantra
Ayurveda Mahavidyalaya and Hospital
Heggeri Extension
Hubballi
Dharwad
KARNATAKA
580024
India |
| Phone |
9445635034 |
| Fax |
|
| Email |
sailash1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Thyagaraja |
| Designation |
Professor and Head of the Department |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital Hubballi |
| Address |
Department of Postgraduate Studies in Shalya Tantra
Ayurveda Mahavidyalaya and Hospital
Heggeri Extension
Hubballi
Dharwad
KARNATAKA
580024
India |
| Phone |
9886245072 |
| Fax |
|
| Email |
drctraja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sailash M |
| Designation |
Postgraduate Scholar |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital Hubballi |
| Address |
Department of Postgraduate Studies in Shalya Tantra
Ayurveda Mahavidyalaya and Hospital
Heggeri Extension
Hubballi
Dharwad
KARNATAKA
580024
India |
| Phone |
9445635034 |
| Fax |
|
| Email |
sailash1999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sailash M |
| Address |
Postgraduate Scholar
Department of Shalya Tantra
Ayurveda Mahavidyalaya and Hospital
Heggeri Extension,
Heggeri Colony
Hubballi 580024 |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ayurveda Mahavidyalaya and Hospital Hubballi |
Heggeri extension
Heggeri Colony
Old Hubli
Hubli - 580024
Dharwad District
Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sailash M |
Ayurveda Mahavidyalaya and Hospital |
Room no. 16-19, Left Wing,
Department of Postgraduate Studies in Shalya Tantra,
Ayurveda Mahavidyalaya and Hospital,
Heggeri Extension,
Hubballi 580024
Dharwad
KARNATAKA |
9445635034
sailash1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurveda Mahavidyalaya and Hospital |
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 | Procedure | - | tailam, तैलम् | (Procedure Reference: Sushruta Samhita Chikitsa Sthana 1st Chapter, Procedure details: Wound Debridement
Prakshalana with Panchavalakala Kashaya for Shodhana Purpose
Anubhoota Yoga is applied over the wound using a gauze piece
Dressing is done)
(1) Medicine Name: Panchavalkala Kashaya, Reference: Bhavaprakasha Poorvakhanda , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 28 Days(2) Medicine Name: Anubhoota Yoga, Reference: Gunapadam Dhatujeeva Vaguppu, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 28 Days(3) Medicine Name: Gandhaka Rasayana, Reference: Yogaratnakara Rasayana Adhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 28 Days | | 2 | Comparator Arm | Procedure | - | tailam, तैलम् | (Procedure Reference: Sushruta Samhita Chikitsa Sthana 1st Chapter, Procedure details: Wound Debridement
Prakshala with Panchavalkala kashaya for Shodhana purpose
Jatyadi Taila is applied over the wound using a gauze piece
Dressing done)
(1) Medicine Name: Panchavalkala Kashaya, Reference: Bhavaprakasha Poorvakhanda, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 28 Days(2) Medicine Name: Jatyadi Taila, Reference: Sarangadhara Samhita, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 28 Days(3) Medicine Name: Gandhaka Rasayana, Reference: Yogaratnakara Rasaya Adhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with features of Dushta Vrana
Patients with wound size not more than 10cm x 5cm x 1cm
Controlled Diabetic Wound |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases like AIDS Tuberculosis Carcinoma Venereal Disease and any other Blood borne Diseases
Patients with Pressure Ulcers Ischemic Ulcer Neurogenic Ulcer Malignant Ulcer Gangrene |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound Healing |
28 days assessed at 7th, 14th and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain Management |
28 days assessed at 7th, 14th and 28th day |
| Reduction in Discharge |
28 days assessed at 7th, 14th and 28th day |
| Difference in Wound Size |
28 days assessed at 7th, 14th and 28th day |
|
|
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 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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 a randomized, parallel-group Clinical Trial comparing the safety and efficacy of Anubhoota yoga (containing Dhattura, Tuttha, Narikela Taila) and Jatyadi Taila in patients with Dushta Vrana. It will be conducted in India. The Primary outcome measure is to determine the wound healing rate in 28 days, assessed on the 7th, 14th and 28th day. The secondary outcomes will be pain management and a reduction in the discharge rate within 28 days. |