| CTRI Number |
CTRI/2025/08/093362 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare the effectiveness of dashang lepa and dhatura lepa in reducing symptoms such as pain , swelling and redness in patients with cellulitis (vranashopha) |
|
Scientific Title of Study
|
A Comparative clinical study of Dashanga lepa and Dhatura lepa in
the management of vranashopha (cellulitis). |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VdVaibhav hari pagore |
| Designation |
P.G Scholer |
| Affiliation |
Ashwin Rural Ayurved College & Hospital manchi hill sangmner ahemadnagar |
| Address |
Opd no 5 , Shlyatantra department ,
Ashwin Rural Ayurved College & Hospital PREETISUDHAJI MAHARAJ NAGAR
Manchi Hill, Ashvi bk,
Taluka: Sangamner,
District: Ahmednagar,
Maharashtra –413714,
India.
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
07218607107 |
| Fax |
|
| Email |
vaibhavpagorepatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd khandizhod shivapal gopalrao |
| Designation |
Head od Department (HOD) |
| Affiliation |
ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL MANCHI HILL, SANGMNER |
| Address |
Opd no 5 Shlyatantra Department,
Ashwin Rural Ayurved College & Hospital PREETISUDHAJI MAHARAJ NAGAR
Manchi Hill, Ashvi bk,
Taluka: Sangamner,
District: Ahmednagar,
Maharashtra
India.413714
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
8975780848 |
| Fax |
|
| Email |
drkhandizod1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Vaibhav Hari Pagore |
| Designation |
P.G SCHOLER |
| Affiliation |
ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL MANCHI HILL SANGMNER |
| Address |
Opd no 5 , Shlyatantra Department,
Ashwin Rural Ayurved College & Hospital PREETISUDHAJI MAHARAJ NAGAR
Manchi Hill, Ashvi bk,
Taluka: Sangamner,
District: Ahmednagar,
Maharashtra –413714,
India.
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
07218607107 |
| Fax |
|
| Email |
vaibhavpagorepatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL PREETISUDHAJI MAHARAJ NAGAR MANCHI HILL ASHVI BK SANGMNER AHEMADNAGAR MAHARASHTRA 413714 india |
|
|
Primary Sponsor
|
| Name |
ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL MANCHI HILL SANGMNER |
| Address |
ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL PREETISUDHAJI MAHARAJ NAGAR ,MANCHI HILL ASHVI BK, SANGMNER, AHEMADNAGAR, MAHARASHTRA 413714 INDIA |
| 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 |
| Vd VAIBHAV HARI PAGORE |
ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL MANCHI HILL |
OPD N0.12 , SHLYATANTRA DEPARTMENT ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL PREETISUDHAJI MAHARAJ NAGAR MANCHI HILL ASHVI BK SANGMNER AHEMADNAGAR 413714 MAHARASHTRA INDIA
Ahmadnagar
MAHARASHTRA |
07218607107
vaibhavpagorepatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL MANCHI HILL ASHVI BK SANGMNER AHEMADNAGAR MAHARASHTRA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L031||Cellulitis and acute lymphangitisof other parts of limb. Ayurveda Condition: VRANASOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhatura lepa , Reference: Bhaishajya ratnavali (47/4), Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 6 Days, anupAna/sahapAna: No, Additional Information: -Lepa application of 1/2 angul praman once daily | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashang lepa, Reference: Sharangdhar samhita chapter -11 , verses 4,5,6, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 6 Days, anupAna/sahapAna: No, Additional Information: Lepa application of 1/2 angul praman on affected area once daily |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Range:
Individuals aged between 12 and 60 years, inclusive.
2. Diagnosis:
Clinically diagnosed cases of Vranashopha (Cellulitis) based on classical Ayurvedic and modern parameters.
3. Location of Lesion:
Lesions must be located on the extremities (upper or lower limbs).
4. Size of Lesion:
Patients with lesion size ranging from 5 cm to 15 cm in diameter (measured with measuring tape or scale).
5. Willingness and Compliance:
Participants must be able and willing to attend regular follow-up visits as per study schedule (Days 0, 2, 4, 6).
Must be willing to follow the treatment regimen, including local application of Lepa.
6. Informed Consent:
Participants (or legal guardians for minors aged 12–17 years) must be willing and able to provide written informed consent in a language they understand |
|
| ExclusionCriteria |
| Details |
Septicemia:
Patients presenting with septicemia or systemic signs of infection requiring emergency care.
2. Surgical Intervention Needed:
Patients who require surgical debridement of the wound.
3. Uncontrolled Diabetes Mellitus:
Patients with uncontrolled blood glucose levels or known cases of poorly managed diabetes.
4. Immunocompromised Status:
Patients with HIV/AIDS or other immunosuppressive conditions.
Patients currently undergoing immunosuppressive therapy.
5. Allergy or Hypersensitivity to Dhatura:
Known hypersensitivity, allergy, or adverse reactions to Dhatura or any ingredients of the lepa.
6. Chronic or Complicated Ulcers/Wounds:
Tubercular ulcers
Venous ulcers
Malignant ulcers
Non-healing wounds (e.g., varicose ulcers)
Kshatavrana (traumatic wounds) with complications such as fractures or marmaghat (vital organ injury)
7. Other Conditions:
Known cases of Hepatitis B or Hepatitis C |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical efficacy of Dashang lepa vs Dhatura lepa in the management of Vranshopha ( cellulitis) |
Day 0 – Baseline (before treatment starts)
Day 2 – First follow-up
Day 4 – Second follow-up
Day 6 – Final assessment (end of treatment period) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall clinical improvement and reduction in subjective and objective symptoms |
0,2 ,4, 6 days |
| Hematological and biochemical changes and time to noticeable symptom relief in pain , swelling, redness and itching . |
0 ,2 , 4 , 6 days |
| Safty , tolerability and adverse reaction of dashang and dhatura lepa |
0, 2, 4, 6 days |
| Patient satisfaction / Compliance with subjective feedback regarding comfort ease of application and perceived improvement. |
0, 2, 4, 6, days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
28/08/2025 |
| 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="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 randomized comparative clinical study aims to evaluate and compare the efficacy of two classical Ayurvedic formulations—Dashanga Lepa and Dhatura Lepa—in the management of Vranashopha (Cellulitis). Vranashopha, described in Ayurvedic texts, resembles modern cellulitis, an inflammatory swelling of soft tissue commonly caused by bacterial infection.
A total of 60 patients (age group: 12–60 years) diagnosed with cellulitis on the extremities, and meeting inclusion criteria, will be enrolled from the OPD/IPD of the Department of Shalya Tantra at Ashwin Rural Ayurved College and Hospital, Sangamner.
Participants will be randomized into two groups:
Group A: Local application of Dashanga Lepa
Group B: Local application of Dhatura Lepa
The Lepa will be applied once daily for 6 days, and patients will be assessed on Day 0, 2, 4, and 6 for changes in symptoms such as pain, swelling, itching, warmth, and redness. Laboratory parameters such as Hb%, TLC, neutrophil count, ESR, and serum creatinine will also be monitored.
The primary objective is to assess which formulation is more effective in reducing symptoms of Vranashopha. Secondary outcomes include laboratory changes, safety, tolerability, and overall clinical improvement. |