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CTRI Number  CTRI/2018/02/011990 [Registered on: 20/02/2018] Trial Registered Prospectively
Last Modified On: 12/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Process of Care Changes 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   EFFECT OF SEASONAL HARITAKI(Terminalia chebula) USE ON IMMUNITY OF THE BODY  
Scientific Title of Study   EFFECT OF RITU HARITAKI ON SHARIRA BALA: A VOLUNTEER BASED STUDY  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prajna Paramita Panda 
Designation  MD Scholar 
Affiliation  All India Institute of Ayurveda 
Address  j404,DDA,Lig flats,gautampuri, sarita vihar New Delhi 110076
Room No.-622 6th floor academic block ,Department of swasthavritta All India Institute of Ayurveda , sarita vihar New Delhi 110076
South
DELHI
110076
India 
Phone  9439444559  
Fax    
Email  dr.prajna.jajpur@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mangalagowri V Rao 
Designation  Associate Professor 
Affiliation  All India Institute of Ayurveda 
Address  Room No.-602 6th floor academic block ,Department of swasthavritta All India Institute of Ayurveda , sarita vihar New Delhi
Room No.-602 6th floor academic block ,Department of swasthavritta All India Institute of Ayurveda , sarita vihar New Delhi 110076
South
DELHI
110076
India 
Phone  8375079795  
Fax    
Email  mangowri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prajna Paramita Panda  
Designation  MD scholar  
Affiliation  All India Institute of Ayurveda 
Address  Room No.-621 6th floor academic block ,Department of swasthavritta All India Institute of Ayurveda , sarita vihar New Delhi

South
DELHI
110076
India 
Phone  9439444559  
Fax    
Email  dr.prajna.jajpur@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Goutam puri Sarita vihar New Delhi 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda  
Address  All India Institute of Ayurveda , Sarita Vihar. New mathura road New Delhi Gautam puri Sarita vihar New Delhi 110076 
Type of Sponsor  Research institution and hospital 
 
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 Mangalagowri VRao  OPD No- 05, Ground floor, Hospital building,All India Institute of Ayurveda   All India Institute of Ayurveda , New Mathura road gautam puri ,Sarita Vihar
South
DELHI 
8375079795

mangowri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy volunteers to improve their immunity 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control groups   Control groups will not undergo any kind of intervention.  
Intervention  Haritaki and guda Haritaki and sharkara  Subjects of study group will take Haritaki churna 3gm two times daily i.e. morning on empty stomach and at night half an hour before taking food with equal amount of guda (jaggery) and warm water in Grishma Ritu or Haritaki churna 3gm two times daily i.e. morning on empty stomach and at night half an hour before taking food with 3gm Sharkara (Rock candy) and warm water in Sharad Ritu  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  BMI above 18.5  
 
ExclusionCriteria 
Details  1 Pregnant or lactating mother
2 Malnourished patients (BMI < 18.5)
3 Subjects with any acute or chronic health problems.
4 Person on any interventional drug like vitamin mineral hormonal supplements protein supplements etc or any other nutritional supplements
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
increase in immunoglobulin (IgG) level and Sharira Bala (Ayurvedic crietria)

 
2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of Haritaki on BMI  2months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   14/05/2018 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The outcome will be published in leading Indian Journals for wider dissemination. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Perfect health is one of cherished wish of all individuals. As per WHO, “Health is defined as a state of complete physical, mental and social wellbeing not merely an absence of disease or infirmity”. Even before that thousands of years back, Ayurvedic Acharyas gave an apt definition of health where it is the balanced state of Doshas, Agni, Dhatus, proper functioning of Malas i.e expulsion of wastes and pleasant state of soul, senses and mind. This state of health can be disturbed due to various factors like seasonal changes, infections, diminution of Agni i.e Jatharagni and Dhatvagni, manasa bhavas like stress, tension, depression etc. Further as per the principles of Ayurveda Agni and Bala are the most important factors responsible for restoration of good health of an individual. Various daily regimen, seasonal regimen, codes and conduct, non-suppression of natural urges, control over the mental states like anger, desire, greed, hatred, attachment etc. have been advocated for Health promotion and disease prevention. Now-a-days people are also suffering from early aging due to improper life style, consumption of food containing harmful chemicals like fertilizers, pesticides, preservatives, environment pollution which leads to accumulation of toxins in the body along with impairment of Agni and diminution of Bala. This results variety of metabolic disorders like diabetes, hypertension, dyslipidemias, obesity, hormonal disorders, early ageing etc.  Even though these disorders are multi factorial basic reason behind them is derangement of Agni and reduction of Bala. Hence to prevent this pathology rectification of Agni and Bala is highly essential. In Ayurveda, Rasayanas have been advocated since time immemorial to enhance Bala.

 In the context of Ritucharya administration of Ritu Haritaki for the purpose of prevention of diseases forms a vital component. Haritaki (Terminalia chebula Linn.) is one among the important Rasayana Dravyas described in our classics for the purpose of Vayasthapana. It has been considered as harmless by Acharya Bhava Mishra “Kadachit Kupyati Mata Nodarastha Haritaki. Hence Ritu Haritaki can be used as Rasayana for rectification of Agni and enhancing Bala or vitality of the body. The present study is designed to scientifically validate the experience based use of Haritaki with different Anupanas (adjuvant) depending on the Ritu

 
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