| CTRI Number |
CTRI/2025/08/093163 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Apamarga Kshar Taila in management of Sharavika Prameha Pidika (Diabetic Ulcers) |
|
Scientific Title of Study
|
AN OPEN RANDOMISED CLINICAL CONTROL TRIAL OF EFFECT OF APAMARGA KSHAR TAILA WITH ADJUVANT DRUG THERAPY IN MANAGEMENT OF SHARAVIKA PRAMEHA PIDIKA WITH SPECIAL REFERENCE TO DIABETIC 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 |
Shaikh Arham Sarosh Mohd Asif |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
3rd Floor Department of Shalya Tantra Hon Shri Annasaheb Dange
Ayurved Medical College Post Graduate and Research Center Ashta
Tal WalWa Dist Sangli
MAHARASHTRA
416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
8928114719 |
| Fax |
|
| Email |
dr.arhamsarosh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Patil |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
3rd Floor Department of Shalya Tantra Hon Shri Annasaheb Dange
Ayurved Medical College Post Graduate and Research Center Ashta
Tal WalWa Dist Sangli
MAHARASHTRA
416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422613195 |
| Fax |
|
| Email |
dr.patilmanoj77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Patil |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
3rd Floor Department of Shalya Tantra Hon Shri Annasaheb Dange
Ayurved Medical College Post Graduate and Research Center Ashta
Tal WalWa Dist Sangli
MAHARASHTRA
416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422613195 |
| Fax |
|
| Email |
dr.patilmanoj77@gmail.com |
|
|
Source of Monetary or Material Support
|
| hon shri annasaheb dange ayurved medical college ashta dist sangli tal walwa maharashtra 416 301 |
|
|
Primary Sponsor
|
| Name |
Shaikh Arham Sarosh Mohd Asif |
| Address |
OPD no 13 Shalya Tantra OPD Ground Floor Dhanvantari Ayurved college hospital Ashta Tal Walwa Dist Sangli
Hospital Ashta Tal WalWa Dist Sangli, Maharashtra 416301 India |
| Type of Sponsor |
Private 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 Manoj Patil |
Hon Shri Annasaheb Dange Ayurved Medical COllege Post Graduate And Research Center Ashta |
opd no 14 ground floor Shalyatantra department Dhanwantri hospital -Hon Shri Annasaheb ayurvedic Medical college and post graduate and research centre ashta sangli
416301
Maharashtra
opd no 14 ground floor Shalyatantra department Dhanwantri hospital -Hon Shri Annasaheb ayurvedic Medical college and post graduate and research centre ashta sangli
416301
Maharashtra
Sangli
MAHARASHTRA |
9422613195
dr.patilmanoj77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E115||Type 2 diabetes mellitus with circulatory complications. Ayurveda Condition: PRAMEHA-PIDAKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | EUSOL | Edinburgh university soluion of lime
composition:1.25g of boric acid, 1.25g bleaching powdwer and sterile water upto 100ml | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Apamarga Kshar Taila, Reference: Sha U 11/145, Route: Topical, Dosage Form: Dravaka, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from Non Insulin Dependent Diabetes mellitus and Insulin Dependent Diabetes mellitus |
|
| ExclusionCriteria |
| Details |
Patient suffering from
Malignant ulcer
Tubercular ulcer
Venous ulcer
HIV and HBsAg |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the efficacy of Apamarga Kshar Taila with adjuvant drug therapy in management of Shravika Prameha Pidika |
at 1st day, 5thday and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of EUSOL & Apamarga Kshar taila with Adjuvant Drug Therapy in manangement of Sharavika Prameha Pidika |
at 1st day , 5th day & 15th day |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
01/09/2025 |
| 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="8"
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
|
Diabetes is a disease known for its multifaceted complications. Diabetic ulcer is one of the major complications of diabetes. Thousands of researches are being carried out on this in which Ayurveda has a major role. Brihatatryis have described Prameha Pidaka as a major complication of Prameha. These Pidakas are mainly found in muscular region, joints and vital points (Marmas). Different numbers of Prameha Pidakas are mentioned in Ayurvedic Classics. According to Sushruta there are 10 different types of Prameha Pidakas.Prameha pidika is seen as debilitating and Scoring disorder seen in the human being suffering from diabetes.it is very important and widely described chapter of shalya tantra.Su.Ni. 6/14 Pidaka which is raised at the margin and dipped in its centre, so as to resemble as Saucer in its shape is called as Sharavika. Diabetese affects more than 9.3% of Indian adult population. Up to 25% of diabetic patients develop foot ulcers. More than half of foot ulcers become infected and require hospitalisation and 20% of infections results in amputation. Early effective management can reduce the severity of complications such as preventable amputations and possible mortality and can also improve overall quality of life. This study is randomized open controlled trial to evaluate the efficacy of Apamarga Kshar taila in the management of Sharavika Prameha PIdika as trial drug and EUSOL as control drug. Trial and control drugs applied on the diagnosed cases of Sharavika prameha pidika for 15 days and as per need. After 15 days patient is advice to come on 5th, 10th, 15 th day for follow up. 44 patients in each group will be studied. Study will be conducted in India. Outcome of study will be asses onbetter healing and reduction of signs and symptoms of wound.
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