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CTRI Number  CTRI/2023/10/058990 [Registered on: 20/10/2023] Trial Registered Prospectively
Last Modified On: 05/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical study to evaluate effectiveness of Shuddha Gandhaka Prayoga in Vicharchika 
Scientific Title of Study   A Clinical study to evaluate the concept of Vyadhi Pratyanika Chikitsa with special reference to Ksheera Gandhaka parayoga in Vicharchika. 
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 Soumya Sajjanar 
Designation  PG Scholar 
Affiliation  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 
Address  Department of Ayurveda Samhita and Siddhanta,3rd floor, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road, Tanniruhalla, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9663365234  
Fax    
Email  soumyasajjanar.7s@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chethan M 
Designation  Professor 
Affiliation  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 
Address  Department of Ayurveda Samhita and Siddhanta,3rd floor, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road, Tanniruhalla, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9663365234  
Fax    
Email  drchethanm@sdmcahhassan.org  
 
Details of Contact Person
Public Query  
Name  Dr Chethan M 
Designation  Professor 
Affiliation  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 
Address  Department of Ayurveda Samhita and Siddhanta,3rd floor, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road, Tanniruhalla, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9663365234  
Fax    
Email  drchethanm@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road, Tanniruhalla, Hassan  
 
Primary Sponsor  
Name  Dr Soumya Sajjanar 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road, Tanniruhalla, Hassan 
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 soumya sajjanar  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN  Skin OPD department of KC room no 4 ,Sri Dharmasthala Manjunatheshwara Hospital, BM Road, Tanniruhalla, Hassan
Hassan
KARNATAKA 		 9663365234

soumyasajjanar.7s@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA & HOSPITAL HASSAN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ksheeragandhaka, Reference: Rasendra Chintamani, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Ksheera), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Chronicity less than 2 years
Localized lesion to certain area will be selected.
Diagnosed cases of sravi and asravi vicharhika
Willingness to participate in the study and ready to sign informed consent form  
 
ExclusionCriteria 
Details  Pregnant and Lactating Women
Subjects on steroids/immunosuppressants
Allergy to sulphur
Subjects with systemic disorders or chronic disorders 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
intervention will be effective in reduction of lesion size, discharge from lesion, pain at lesion site, itching.  after 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of Ayurveda Concept of Vyadhi Prtyanika Chikitsa will be done.
effectiveness of Shuddha Gandhaka as Vyadhi Pratyanika in Vicharchika lakshanas such as itching, lesion size, discharge, pain at lesion site will be noted. 		 24 weeks (6 month inculding trail period) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   21/10/2023 
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="0"
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  

Title: A CLINICAL STUDY TO EVALUATE THE CONCEPT OF VYADHI PRATYANIKA CHIKITSA WITH SPECIAL REFERENCE TO KSHEERA GANDHAKA PRAYOGA IN VICHARCHIKA

Purpose: To validate the concept of Vyadhipratyanika chikitsa in Vicharchika using Ksheera Gandhaka for period of 15 days. Gandhaka is mentioned as drug of choice in Rasendra Chintamani and Caraka Mentions Gandhaka Prayoga for all types of Kushta; it possesses qualities like Kushtahara, Kandughna, Visrpahara, Vishahara, Rasayana guna etc. by the virtue of Katu Tikta Rasa, Ushnaveerya and it will act against Vicharchika. Ksheera Gandhaka is a simple yoga for administration and easily available and cost effective. There are less works dedicated towards Gandhaka Prayoga and anupana as Ksheera, hence a thorough work on its action and efficacy is required.

Methods: Vicharchika is classified into two groups based on the lakshana (Sravi and Asravi) and 20 subjects in each group. Both the groups will be given 6-12g of Triphala Churna condsidering the koshta of subjects for Ksohta Shuddhi. Later both the groups will be given at the dose of 1g. Shuddha Gandhaka(Shodhana as per Rasaratna Samucchaya) and Ksheera as Anupana and Ksheeranna Bhojana as Pathya. Assessments will be carried out on 0th, 8th day. Follow up on the 15th day. Standard proformas will be used for assessment and follow up.

Results: Results will be tabulated and statistically treated by Wilcoxon Sign Rank Test and Friedm’s test, Whitney U Test and Paired T Test.

Conclusion: The study will help understand Vyadhipratyanika Chikitsa Concept in Vicharhika and provides a window to understand how Shuddha Gandhaka Works with Ksheera as anupana.  
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