| CTRI Number |
CTRI/2025/04/084206 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study Of Jatyadi Ghrita Vranabasti With And Without Vranadhoopana in The Management Of Dushta Vrana |
|
Scientific Title of Study
|
A Clinico Comparative Study Of Jatyadi Ghrita Vranabasti With And Without Vranadhoopana 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 |
Radhika S Bhuva |
| Designation |
PG Scholar |
| Affiliation |
Goverment Akhandanand Ayurved College And Hospital |
| Address |
Department of Shalya Tantra OPD No 14 Government Akhandanand
Ayurved College and Hospital Ahmadabad Gujarat 380001 India
Ahmadabad
GUJARAT
380001
India
Ahmadabad
GUJARAT
380001
India |
| Phone |
7016883046 |
| Fax |
|
| Email |
bhuvaradhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harshit S Shah |
| Designation |
Pricipal and Professor |
| Affiliation |
Goverment Akhandanand Ayurved College And Hospital |
| Address |
Department of Shalya Tantra OPD No 14 Government Akhandanand
Ayurved College and Hospital Ahmadabad Gujarat 380001 India
Ahmadabad
GUJARAT
380001
India
Ahmadabad
GUJARAT
380001
India |
| Phone |
9824068160 |
| Fax |
|
| Email |
sejharsh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshit S Shah |
| Designation |
Pricipal and Professor |
| Affiliation |
Goverment Akhandanand Ayurved College And Hospital |
| Address |
Department of Shalya Tantra OPD No 14 Government Akhandanand
Ayurved College and Hospital Ahmadabad Gujarat 380001 India
Ahmadabad
GUJARAT
380001
India
Ahmadabad
GUJARAT
380001
India |
| Phone |
9824068160 |
| Fax |
|
| Email |
sejharsh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurved College and Hospital Bhadra Ahmedabad 380001 |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurved College and Hospital |
| Address |
Department of Shalya Tantra OPD 14 Government Akhandanand
Ayurved College And Hospital Bhadra Ahmedabad
Gujarat 380001 India
|
| Type of Sponsor |
Government medical college |
|
|
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 Radhika S Bhuva |
Government Akhandanand Ayurved College and Hospital |
Department of Shalya
Tantra OPD 14
Government
Akhandanand Ayurved
College And Hospital
Bhadra Ahmedabad
Gujarat 380001 India
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
7016883046
bhuvaradhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Akhandanand Ayurved College and Hospital |
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, (2) ICD-10 Condition:L80-L99||Other disorders of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vraNadhUpanam, व्रणधूपनम् | (Procedure Reference: Su chi 1, Procedure details: once in a day morning for 20 min
21 days)
(1) Medicine Name: Rakshoghna Dhupana Dravya, Reference: Su Su 5, Route: Topical, Dosage Form: Churna/ Powder, Dose: 30(g), Frequency: od, Duration: 21 Days | | 2 | Intervention Arm | Procedure | - | bastikarma, बस्तिकर्म | (Procedure Reference: su chi 1, Procedure details: Once in A day for 20 min
21 days)
(1) Medicine Name: Jatyadi Ghrita, Reference: Harita Samhita Tritiya Sthana 35, Route: Topical, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 21 Days | | 3 | Comparator Arm | Procedure | - | bastikarma, बस्तिकर्म | (Procedure Reference: Su Chi 1, Procedure details: Once in a day for 20 mins
21 days)
(1) Medicine Name: Jatyadi Ghrita, Reference: Harita Samhita Tritiya Sthana 35, Route: Topical, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Venous ulcer Diabetic wound
Fails to heal within 4 weeks
Traumatic wound which fail to heal
Infectious Wound
Pressure sore
|
|
| ExclusionCriteria |
| Details |
Patients having pre-gangrenous or gangrenous changes
Patients suffering from Osteomyelitis
Patients suffering from HIV and Immunodepressant diseases
Present on all movable and highly moving joints
Vulnerable group of people like mentally ill
Pressure sore on sole
Leprosy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of Dustavrana |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve quality of life of patient |
21 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="2"
Months="0"
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
|
Maharshi
Sushruta
has emphasized on Vrana and has given detailed description of Vrana
and its management of Vrana is a subject of matter for Shalyatantra.
The study of Shlyatantra brings out very clearly that Vrana is
the most significant surgical entity and knowledge of its effective management
for a surgeon which is required basic skill on which the outcome of surgery
revolves. Dushta
Vrana is one of the Vranas which needs treatment
for healing, it is necessary to remove maximum Dushti by the virtue of Shodhana,
Krimighna, Stravahara, Dahaprashamana and Vrana Ropaka drug. Alleviating
these inhibitory factors is goal of Shodhanachikitsa by Dhoopana
karma. Shodhanachikitsa and Ropanachikitsa by Jatyadi Ghrita
Vranabasti follow further The increasing prevalence of non-healing wounds demands potential
research work on this entity so it is need of time to prove the efficacy of
Ayurveda intervention in the management of non-healing wounds. Acharya Sushruta describes sixty
measures for wound management that include a variety of treatment measures such
as Kalka, Kashaya, Varti, Taila, Ghrita, etc. Till date, no research
work has been done on Jatyadi Ghita Vranabasti with Vranadhoopana
for their efficacy in non-healing wounds. |