| CTRI Number |
CTRI/2025/11/097191 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| 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 Comparing Ayurvedic Herbal Smoke Therapy and Oxygen Exposure Therapy For Faster Healing of Diabetic Foot Ulcer |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Evaluate The Efficacy of Vranadhoopan And Hyperbaric Oxygen Therapy In The Management of Diabetic Foot 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 Jignesh Babubharthi Goswami |
| Designation |
PG Scholar |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies And Research |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT
388120
India |
| Phone |
9664508811 |
| Fax |
|
| Email |
jigsgoswami3131@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay L Trivedi |
| Designation |
Professor |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT
388120
India |
| Phone |
9428628046 |
| Fax |
|
| Email |
drsanjaytrivedi888@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay L Trivedi |
| Designation |
Professor |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT
388120
India |
| Phone |
9428628046 |
| Fax |
|
| Email |
drsanjaytrivedi888@gmail.com |
|
|
Source of Monetary or Material Support
|
| S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120 |
|
|
Primary Sponsor
|
| Name |
Dr Jignesh Babubharthi Goswami |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120 |
| 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 Jignesh Babubharthi Goswami |
S. G. Patel Ayurveda Hospital and Maternity Home |
Department of Shalya Tantra, OPD No. 25, New Vallabh vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT |
9664508811
jigsgoswami3131@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G. J. Patel Institute Of Ayurvedic Studies And Research, S.G.Patel Ayurveda Hospital and Maternity Home Institutional (Human) Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A Vranadhoopan with Nirgundyadi Dhoop |
After cleaning the wound with antiseptic solution, varti made up from nirgundyadi dhoopa exposed on the wound throgh funnel shaped devise for 10 minutes Daily. time duration of whole procedure is 15 days or up to healing whichever is less. |
| Comparator Agent |
Group B Hyperbaric Oxygen Therapy |
After cleaning the wound apply sterile plastic bag over the wound then after insert the oxygen cannula through one side of the bag and close both end of the bag with adhesive tape and then give the exposure ofoxygen through cannula over the wound. keep it for 45 minutes and then after slowly remove the tape and bag than apply sterile dressing. this procedure time duration will be 15 days or up to healing whichever is less. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age Group-Patients between 18 to 70 years with clinically diagnosed Diabetic Foot Ulcer. Type of Ulcer Presence of chronic, non-healing Diabetic Foot Ulcer for at least 2 Weeks. Size of the wound greater than 4 sq cm to less than 10sq cm. Wound Classification-Wagner classification Grade 1 to 3 ulcers (no gangrene). Blood Sugar Levels- HbA1c less than 7 percent. Irrespective of age gender Religion Occupation and economic status. |
|
| ExclusionCriteria |
| Details |
Age Below 18 and Above 70.
Size of wound less than 4 sq cm and greater than 10 sq cm.
Severe Ulcers, Wagner’s Grade 4 and 5 ulcers (gangrene or extensive necrosis).
Uncontrolled Diabetes HbA1c greater than 7 percent.
Patients with wounds other than Diabetic wounds. Any comorbid condition except diabetes.
Pregnant lady & lactating women.
Diagnosed cases of HIV and HbsAg. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Objective criteria Bates Jensen Wound Assessment Tool Subjective Criteria VRS (Verbal Rating Scale) for Pain Burning sensation and Itching Sensation |
Duration 15 Days or up to healing
Whichever is less Follow up Up to 1 month every 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
01/12/2025 |
| 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) |
Open to Recruitment |
|
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 synopsis titled “A Randomized Comparative Clinical Study to Evaluate the Efficacy of Vranadhoopan and Hyperbaric Oxygen Therapy in the Management of Diabetic Foot Ulcer” aims to scientifically assess two distinct therapeutic approaches—an Ayurvedic fumigation method (Vranadhoopan) and a modern oxygen-based therapy (HBOT)—in treating diabetic foot ulcers. Diabetic foot ulcer is a major complication of diabetes, often leading to infection, amputation, and disability. Ayurveda correlates it with Pramehaj Vrana, described as a chronic non-healing wound caused by vitiated doshas. The study integrates the Ayurvedic concept of Vranadhoopan—fumigating wounds with herbal smoke (Nirgundyadi Dhoopa containing Nirgundi, Nimba, Hartala, Sarshapa, etc.)—which possesses antimicrobial, anti-inflammatory, and wound-healing properties. In comparison, Hyperbaric Oxygen Therapy (HBOT) enhances tissue oxygenation, angiogenesis, and collagen synthesis, promoting faster healing. The study is designed as a randomized comparative clinical trial on 32 patients diagnosed with diabetic foot ulcers, divided equally into two groups—Group A (Vranadhoopan) and Group B (HBOT). Treatment will be administered daily for 15 days, followed by a one-month follow-up. Assessment will be done using the Bates-Jensen Wound Assessment Tool, evaluating parameters like pain, burning, itching, exudate, granulation, and epithelization. The research seeks to determine the relative efficacy, safety, and cost-effectiveness of both therapies. Expected outcomes include faster wound healing, enhanced granulation and epithelialization, and reduced infection risk. This integrative approach aims to validate Ayurvedic wound management scientifically and offer a cost-effective alternative for diabetic foot ulcer treatment. |