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CTRI Number  CTRI/2022/06/043513 [Registered on: 27/06/2022] Trial Registered Prospectively
Last Modified On: 16/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Survey of skin diseases occurring in North east India and to find out the effectiveness of an ayurvedic medicine viz. Kandughna Mahakashay vati on particular skin disease with round patches on body associated with itching. 
Scientific Title of Study   An Epidemiological Study of Skin Diseases Occurring in North East India and Clinical Efficacy of Kandughna Mahakashaya Vati w.r.t. Dadru Kushtha 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Rahangdale 
Designation  PhD Scholar, Dept. of Ayurved Samhita Evum Siddhant 
Affiliation  Shri Krishna Ayush University, Kurukshetra (Haryana) 
Address  Regional Ayurveda Research Center, First Floor, CMO Building, Regional Ayurveda Research Centre, Civil Hospital Colony, Dimapur.

Dimapur
NAGALAND
797112
India 
Phone  8302203962  
Fax    
Email  liveayubest@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Baldev Kumar 
Designation  Vice Chancellor 
Affiliation  Dept. of Ayurved Samhita Evum Siddhant Shri Krishna Ayush University, Kurukshetra (Haryana) 
Address  Dept. of Ayurved Samhita Evum Siddhant, Shri Krishna Ayush University, Sector 8, Umri road, Kurukshetra, Haryana

Kurukshetra
HARYANA
136131
India 
Phone  9414238740  
Fax    
Email  hemadriayurveda@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhuvnesh Kumar Sharma 
Designation  Associate Professor 
Affiliation  Dept. of Ayurved Samhita Evum Siddhant  
Address  Dept. of Samhita and Maulik Siddhant, National Institute of Ayurveda, Deemed to be University, Jaipur.

Jaipur
RAJASTHAN
302002
India 
Phone  9441229904  
Fax    
Email  dr_bhuvnesh@yahoo.co.in  
 
Source of Monetary or Material Support  
Regional Ayurveda Research Centre, CMO Building, District Hospital Colony, Dimapur, Nagaland 
 
Primary Sponsor  
Name  Deepak Y Rahangdale 
Address  At Post-Navezari, Tah-Tirora, Dist-Gondia, Maharashtra 
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 Deepak Rahangdale  Reginal Ayurveda Research Centre, Dimapur  First Floor, CMO Building, District Hospital Colony, Dimapur, Nagaland
Dimapur
NAGALAND 		 8302203962

liveayubest@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, RARC, DIMAPUR  Approved 
Institutional Ethics Committee, Shri Krishna Ayush University, Kurukshetra, Haryana, India.  Approved 
Regional Ayurveda Research Centre, Central Council of Research in Ayurvedic Sciences, Dimapur, Nagaland  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, (2) ICD-10 Condition:L299||Pruritus, unspecified. Ayurveda Condition: KUSHTHAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kandughna Mahakashaya, Reference: Charaksamhita Sutrasthan 4/11, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals coming under diagnostic criteria and with classical sign and symptoms of Kushtha viz. skin disease. 
 
ExclusionCriteria 
Details  Patients with other systemic disorders 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
An epidemiology of skin diseases occurring in north east India and clinical efficacy of Kandughna Mahakashaya Vati w.r.t. Dadru Kushtha will be assessed on the basis of changes in subjective parameters 1. Kandu 2. Raga(Reddish nodules) 3. Pidaka (Papule/eruptions) 4. Udagatmandalam(elevated ring shaped plaque) 5. Dirghapratana(spreading out) 6. Durvavata (Resembling Durva) 7. Atasikusumachavi( Resembling the flower of Atasi) 8. anusangini(Chronic/associated over a long period) 9. Tamravarna  AT THE END OF THE TRIAL of 28 days and follow up of 15 days for 1 month. 
 
Secondary Outcome  
Outcome  TimePoints 
Able to ascertain relationship between cause and effect in relation to Nidana/hetu and skin diseases.  After the observations and results are tabulated. 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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 1/ Phase 2 
Date of First Enrollment (India)   30/06/2022 
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="0"
Months="0"
Days="28" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
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-identification.

  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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 26-10-2022 and end date provided 08-06-2023?
    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  

Skin disorders constitute one of the largest groups of health problems in general practice and hospital reporting patients. The disease can’t occur in an individual unless and until there are many factors which come together that’s why many times it is said that there is a multifactorial origin for occurrence of any particular disease and we all know, the environment which is surrounding us and the society in which we live, plays a very significant role in occurrence of diseases. There could be factors like climatic, housing, the vector around us, the animals around us, various socio-cultural practices that we follow, all these factors can affect not only the health of individuals which could be physical or mental as well but they can lead to a occurrence of disease as well. According to Samhitas the factors which influence the production of skin disease are diet and habits of the individual, for which he is habituated for a long time. Intolerance to food is mentioned as one of the important cause for various skin manifestations in the contemporary medicine also. A study is required to observe the role of different causative factors for skin disorders with respect to food habits and personal habits of the individual influence the causation as explained in Samhitas. Hence a cross sectional survey study will be conducted to find out the prevalence of different Rakta-dustinidana viz. etio-pathogenesis of blood) along with other Nidana’s for the manifestation of classical Kushtharoga viz. skin disorders.Similarly along with this it will be an interventional study in sample size of 100 patients, which attempt to test the trial drug i.e Kandughna Mahakashaya Vati on Dadru Kushtha. 

 
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