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CTRI Number  CTRI/2024/11/077392 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [External application ]  
Study Design  Single Arm Study 
Public Title of Study   Effect of Darvi Guduchyadi Ghan Vati and Tundi Ghrit in Vipadika 
Scientific Title of Study   Prospective single arm open clinical trial to study the efficacy of Darvi Guduchyadi Ghan Vati and local application of Tundi Ghrit in the management of Vipadika  
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 Aishwarya Pralhad Mule  
Designation  PG Scholar  
Affiliation  Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya,Satara  
Address  PG department of Kayachikitsa Dr M N Aagashe Aryangla Hospital, Shukrawar Peth Satara

Satara
MAHARASHTRA
415002
India 
Phone  9011011792  
Fax    
Email  aishwaryamule24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sameer Pralhad Shinde  
Designation  Associate Professor  
Affiliation  Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara  
Address  PG department of Kayachikitsa, Cabin no 2 Dr M N Aagashe Aryangla Hospital Shukrawar Peth Satara

Satara
MAHARASHTRA
415002
India 
Phone  7507043414  
Fax    
Email  sameershubha85@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aishwarya Pralhad Mule  
Designation  PG Scholar  
Affiliation  Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Satara Gendamal ITI road Shahupuri Satara  
Address  PG department of Kayachikitsa Dr M N Aagashe Aryangla Hospital Shukrawar Peth Satara Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Gendamal ITI road Shahupuri Satara

Satara
MAHARASHTRA
415002
India 
Phone  9011011792  
Fax    
Email  aishwaryamule24@gmail.com  
 
Source of Monetary or Material Support  
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Satara pin 415002 Maharashtra India  
 
Primary Sponsor  
Name  Dr Aishwarya Pralhad Mule  
Address  Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Satara Gendamal, ITI road, Shahupuri, Satara PIN 415002 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aishwarya Pralhad Mule   Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya   Room no 4 OPD block Department of Kayachikitsa Dr M N Aagashe Aryangla Hospital Shukrawar Peth Satara
Satara
MAHARASHTRA 		 9011011792

aishwaryamule24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SCM Aryangla Vaidyak Mahavidyalaya Satara   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VIPADIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Darvi Guduchyadi Ghan Vati , Reference: Sahastrayogam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -jal), Additional Information: The drug contains Berberis aristata tinospora cordifolia picrorhiza kurroa acorus calamus rubia cordifolia azadirachta indica embelica officinalis terminalia chebula terminalia belerica that are useful in all types of skin disease
2Intervention ArmDrugClassical(1) Medicine Name: Tundi Ghrit , Reference: Yogaratnakara, Route: Topical, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: This drug contains cephalandra indica leaves and fruit of this plant has anti-inflammatory and healing properties that helps to cure Vipadika and inhibits recurrence of disease
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 patients having clinical signs and symptoms of Vipadika like panipadasphutanam (cracks/fissures on palms or soles),vedana (pain),kandu (itching),saraga pitika(red coloured pustules on palms and soles),twakrukshata(roughness of skin) described in Ayurvedic classics without any bar of caste,sex, religion
2 patients having chronicity of Vipadika under 5 years 
 
ExclusionCriteria 
Details  1 pregnant and lactating mothers.
2 patients with serious illness like HIV, Malignancy, major liver disorders,end stage renal disease.
3 patients having bleeding disorders.
4 patients taking immunosuppressive therapy. 
 
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 
To evaluate the efficacy of Darvi Guduchyadi Ghan Vati and local application of Tundi Ghrit in Vipadika   11 th day ,21 th day 
 
Secondary Outcome  
Outcome  TimePoints 
1 To study the efficacy of Darvi Guduchyadi Ghan Vati and local application of Tundi Ghrit in Vipadika
2 To study the etiopathology of Vipadika
3 To study adverse effect of Darvi Guduchyadi Ghan Vati if any
4 To study adverse effect of Tundi Ghrit if any. 		 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 3 
Date of First Enrollment (India)   12/12/2024 
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)
Modification(s)  		 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aishwaryamule24@gmail.com].

  6. For how long will this data be available start date provided 30-11-2024 and end date provided 30-11-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Single arm open clinical trial 

This study is conducting to evaluate the efficacy of Darvi Guduchyadi Ghan Vati and local application of Tundi Ghrit in Vipadika .
After screening patients at OPD and IPD level 30 patients will be selected for trial , informed written consent will be taken in native language.
Vipadika is one of the kshudra kushtha.It involves predominantly vata and kapha dosha and is characterized by pani-pada sphutanam(fissure in palms and soles),severe pain (teevra vedana).since there is no satisfactory treatment for Vipadika in conventional medicine, Ayurvedic treatment can provide promising results in this condition which is effective and prevents its recurrence.

Null hypothesis 

Darvi Guduchyadi Ghan Vati (500 mg) and local application of Tundi Ghrit twice a day for 21 days is not significantly effective in Vipadika.

Alternate hypothesis 

Darvi Guduchyadi Ghan Vati (500mg) and local application of Tundi Ghrit twice a day for 21 days is significantly effective in Vipadika.

Drug- Darvi Guduchyadi Ghan Vati 
Dose- 500 mg twice daily orally
Anupana-koshna jala
Sevan kala- vyanodan (after food)
Duration - 21 days
Follow up -11 th day and 21 st day


Drug-Tundi Ghrit
Dose- local application as necessary 
Kala- two times a day 
Duration -21 days
Follow up - 11th day and 21 st day.

 
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