| CTRI Number |
CTRI/2026/04/107584 [Registered on: 06/04/2026] Trial Registered Prospectively |
| Last Modified On: |
03/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of dhatur mul churna+ saidhav lepa on late stage of vranashopha before formation of vrana |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of dhaturmul churna and saidhav lepa in management of vranastitharambhak vranashopha w.s.r. to 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 |
Vd Jyoti vikas gurav |
| Designation |
PG Scholar |
| Affiliation |
Late kedari redekar ayurvedic mahavidyalaya and PG research centre gadhinglaj, district -kolhapur 416502, maharashtra,India |
| Address |
Shalyatantra OPD ground floor, LKR hospital ,p-2 MIDC area,shendri mal,gadhinglaj
Dist.-Kolhapur
MAHARASHTRA , INDIA
416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7057372488 |
| Fax |
|
| Email |
jyotiredekar5566@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjit vilasrao kadam |
| Designation |
B.A.M.S. M.S. shalyatantra |
| Affiliation |
Late kedari redekar ayurvedic mahavidyalaya and PG research centre gadhinglaj |
| Address |
Shalyatantra OPD ground floor, LKR hospital ,p-2 MIDC area,shendri mal,gadhinglaj
Dist.-Kolhapur
MAHARASHTRA , INDIA
416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9595353549 |
| Fax |
|
| Email |
ranjitkadam96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Jyoti vikas gurav |
| Designation |
PG scholar |
| Affiliation |
Late kedari redekar ayurvedic mahavidyalaya and PG research centre gadhinglaj , district- kolhapur, maharashtra, India pincode-416502 |
| Address |
Shalyatantra OPD ground floor, LKR hospital ,p-2 MIDC area,shendri mal,gadhinglaj
Dist.-Kolhapur
MAHARASHTRA , INDIA
416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7057372488 |
| Fax |
|
| Email |
jyotiredekar5566@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late kedari redekar ayurvedic mahavidyalaya and PG research centre gadhinglaj.
p-2 MIDC area shendri mal gadhinglaj
Dist-Kolhapur
MAHARASHTRA
INDIA
pincode -416502 |
|
|
Primary Sponsor
|
| Name |
Vd Jyoti vikas gurav |
| Address |
Late kedari redekar ayurvedic mahavidyalaya and PG research centre gadhinglaj p-2 MIDC area shendri mal gadhinglaj
Dist-Kolhapur
MAHARASHTRA
INDIA
pin code -416502 |
| 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 Jyoti vikas gurav |
Late kedari redekar ayurvedic mahavidyalaya and PG research centre gadhinglaj |
Late kedari redekar ayurvedic mahavidyalaya and PG research centre gadhinglaj p-2 MIDC area shendri mal gadhinglaj
Dist-Kolhapur
MAHARASHTRA, INDIA
pincode -416502
Kolhapur
MAHARASHTRA |
07057372488
jyotiredekar5566@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Late kedari redekar ayurvedic mahavidyalaya gadhinglaj ,p-2 MIDC area, shendri mal, gadhinglaj, Maharashtra, India.pincode -416502 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L029||Cutaneous abscess, furuncle and carbuncle, unspecified. Ayurveda Condition: VRANASOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhaturmul churna+saidhav , Reference: Bhaishajya ratnawali 47/4, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Glycerine Mgso4 dressing | Route-local application
Duration - 1 week
Frequency - OD |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects or a legally authorized representative must provide written informed
consent.
2. Shotha which are restricted to localised area.
a) Size Upto 20-25 cm.
b) Age groups: Above 18 yrsto 60 yrs
c) All cases of Cellulitis which shows Varna – Pita, Sarakta. Sparsh –
Mrudu.
Lakshane Sheeghra Anusaryen, Chosha, Daha etc.
|
|
| ExclusionCriteria |
| Details |
Patientsuffering from Hepatitis B, HIV, HBSAG or any other systemic infection.
2. Patientsin Sepsis, and patientsthatrequire debridgement.
3. Subjects who require other emergency operations(major
surgical procedure).
4. Subjects with Known cases of Diabetes mellitus or Gangrenous ulcer.
5. Ulcer secondary to any malignancy.
6. Immuno-compromised patients.
7. Patient below 17 year of age.
8. Osteomyelitis.
9. Patient suffering from wounds like Tuberculosis, Venous Ulcers, Leprotic
Ulcers, Malignant Ulcers.
|
|
|
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 |
EFFICACY OF
Dhatura mul CHURNA + SAINDHAV LEPA IN MANAGEMENT OF
VRANASTITARAMBHAK VRANASHOPHA |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study classical literature of vranashopha |
7 days |
| To study lepan vidhi in detail |
7 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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/05/2026 |
| 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) |
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 controlled clinical trial to evaluate the efficacy of dhaturmul churna+ saidhav lepe in management of vranastitharambhak vranashopha w.s.r. to cellulitis. Total 60 patients of age 18 years to 60 years of both sex will be randomly selected for this trial and divided in two groups. Group A : treated with dhatur mul churna+saidhav lepa(daily once a day)and tab.augmentin 30-50 mg/kg body weight daily . Group B : treated with glycerine Mgso4 dressing (daily once a day) and tab. Augmentin 30-50 mg /kg body weight daily . Data will be analysed and statistical tests will be applied . Results will be presented |