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CTRI Number  CTRI/2025/05/087926 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 29/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   Survey Study To Assess Pitta Dosha Vriddhi During Sharad Ritu Following Routine Diet In Volunteers  
Scientific Title of Study   Assessment Of Pitta Dosha Vriddhi During Sharad Ritu In Volunteers Following Routine Diet-Observation Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
no  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Archana Nautiyal Bhatt 
Designation  MD Scholar 
Affiliation  Uttaranchal Ayurvedic College And Hospital 
Address  Department Of Ayurved Samhita Evum Siddhant Uttaranchal Ayurvedic College And Hospital 17 0ld Mussoorie Road Rajpur Dehradun Uttarakhand
Department Of Ayurved Samhita Evum Siddhant Uttaranchal Ayurvedic College And Hospital 17 0ld Mussoorie Road Rajpur Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248009
India 
Phone  09411128014  
Fax    
Email  Nautiyalarchi2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ved Bhushan Maithani 
Designation  Associate Professor 
Affiliation  Uttaranchal Ayurvedic College And Hospital 
Address  Department Of Ayurved Samhita Evum Siddhant Uttaranchal Ayurvedic College And Hospital 17 0ld Mussoorie Road Rajpur Dehradun Uttarakhand
Department Of Ayurved Samhita Evum Siddhant Uttaranchal Ayurvedic College And Hospital 17 0ld Mussoorie Road Rajpur Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248009
India 
Phone  09411128014  
Fax    
Email  shekharmaithani19@gamil.com  
 
Details of Contact Person
Public Query  
Name  Archana Nautiyal Bhatt 
Designation  MD Scholar 
Affiliation  Uttaranchal Ayurvedic College And Hospital 
Address  Department Of Ayurved Samhita Evum Siddhant Uttaranchal Ayurvedic College And Hospital 17 0ld Mussoorie Road Rajpur Dehradun Uttarakhand
Department Of Ayurved Samhita Evum Siddhant Uttaranchal Ayurvedic College And Hospital 17 0ld Mussoorie Road Rajpur Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248009
India 
Phone  09411128014  
Fax    
Email  Nautiyalarchi2@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Archana Nautiyal Bhatt 
Address  Uttaranchal Ayurvedic College and hospital 17 Old Mussoorie Road Rajpur Dehradun 248009 Uttarakhand 
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 Archana Nautiyal Bhatt  Uttaranchal Ayurvedic College and hospital and Different areas of Dehradun  17 Old Mussoorie Road Rajpur Road ,Dehradun 248009 Dehradun Uttarakhand
Dehradun
UTTARANCHAL 		 9411128014

Nautiyalarchi2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Uttaranchal Ayurvedic College Dehradun  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not Specific Condition 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Healthy volunteers age group 18-60 yrs irrespective of sex, religion, socio-economic status.
2.Heathy volunteers will be assessed in Sharad Ritu i.e months of September, October, November.
3.volunteers will be enrolled for study before starting the Sharad Ritu. 
 
ExclusionCriteria 
Details  1.Below 18 years and above 60 years
2.Known cases of any chronic or acute illness.
3.Known cases of any surgical intervention or physical trauma.
4.Pregnant women and lactating mother 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the manifestation of pitta dosha vriddhi during sharad Ritu using a structured symptoms based questionnaire, and to evaluate the correlation between routine dietary patterns and the intensity of Pitta Vriddhi lakshanas in healthy volunteers.  1.Baseline at the onset of Sharad Ritu
2.one month after the onset of Sharad Ritu
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   N/A 
Date of First Enrollment (India)   15/07/2025 
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="0"
Months="3"
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   Lifestyle disease are a result of an inappropriate relationship of people with their environment. Every Ritu has its own impact on the environment and human body. This observation study aims to assess the vriddhi of Pitta Dosha during Sharad Ritu in healthy volunteers who follow a routine diet. The primary objective is to observe the manifestation of pitta related symptoms using a structured questionnaire and to evaluate the influence of routine dietary habits on these symptoms. Data will be collected at baselines  and after one month follow up during Sharad Ritu. The study does not involve any intervention or administration of pitta aggravating substances. Dietary intake will be recorded only to track the frequency and type of routine  foods consumed. 
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