| 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
|
|
|
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
|
|
|
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 infirmityâ€. 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. |