| CTRI Number |
CTRI/2024/12/078483 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Dietary supplement , exercise] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of efficacy of Vyayama(Physical Exercise)alone Versus Vyayama with Dates Fruit(Phoenix dactylifera Linn.) on Yuktikruta Sharira Bala (Physical Fitness) in apparently
healthy individuals |
|
Scientific Title of Study
|
A comparative study to evaluate efficacy of Vyayama(Physical Exercise)alone Versus
Vyayama with Dates Fruit(Phoenix dactylifera Linn.)as Balya Ahariya Dravya
(strengthening food item) on Yuktikruta Sharira Bala (Physical Fitness) in apparently
healthy individuals:An Open-labelled Randomized Control Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshit Gupta |
| Designation |
M.D. Scholar |
| Affiliation |
All India Institute Of Ayurveda New Delhi |
| Address |
Room no 312 Department of Kriyasharira Academic block All India
Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
9896398235 |
| Fax |
|
| Email |
harshitguptanrw01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Vilas Ohol |
| Designation |
Professor |
| Affiliation |
All India Institute Of Ayurveda New Delhi |
| Address |
Room no 301 Department of Kriyasharira Academic block All India
Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
9029765299 |
| Fax |
|
| Email |
drsaritav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshit Gupta |
| Designation |
M.D. Scholar |
| Affiliation |
All India Institute Of Ayurveda New Delhi |
| Address |
Room no 312 Department of Kriyasharira Academic block All India
Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
9896398235 |
| Fax |
|
| Email |
harshitguptanrw01@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda New Delhi |
| Address |
All India Institute of Ayurveda Gautampuri 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 Harshit Gupta |
All India Institute Of Ayurveda New Delhi |
Room No 312
Department of
Kriyasharira Academic
block All India Institute
Of Ayurveda
Gautampuri Sarita
Vihar New Delhi
110076
South
DELHI |
9896398235
harshitguptanrw01@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 |
Apperantly Healthy individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: NA, Ritucarya: NA, Acara Rasayana:Dates Fruit (Phoenix dactylifera Linn.) as Balya Ahariya Dravya (strengthening food item) Dose 40-50 g per day Duration 30 days Consumption will be recommended empty stomach in morning before vyayama Vyayama Physical Exercise 20-40 minutes daily Duration 30 days in morning after eating dates, Other:NA, Pathya/Apathya:yes, Pathya:Selection of Ahara Dravya as per different Ritu. Always eat the food which is Snigdha (demulcent) Laghu (easily digestible) and Ushna (warm). At the beginning of the meal eat sweet substances in the middle food articles have a sour and salty taste and in the end food articles of remaining tastes. Eat twice a day and keep the time of meals fixed as much as possible. Eat food in proper quantity containing all the six rasas, Apathya:Eating too slowly or too fast. Talking and laughing while having food. Eating incompatible food combinations. Day sleep except in Grishma Ritu (summer season). Eating reheated food or burnt food. Taking food articles of one taste only. Eating pishttanna (processed food prepared from rice flour). Too much liquid in a large quantity. Eating packaged food from the outside. Consuming too much sugar & sweets. Consuming too spicy sour food items | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: NA, Ritucarya: NA, Acara Rasayana:Vyayama Physical Exercise 20-40 minutes daily Duration 30 days in morning after eating dates, Other:NA, Pathya/Apathya:yes, Pathya:Selection of Ahara Dravya as per different Ritu. • Always eat the food which is Snigdha (demulcent) Laghu (easily digestible) and Ushna (warm). At the beginning of the meal eat sweet substances in the middle food articles have a sour and salty taste and in the end food articles of remaining tastes. Eat twice a day and keep the time of meals fixed as much as possible. Eat food in proper quantity containing all the six rasas., Apathya:Eating too slowly or too fast. Talking and laughing while having food. Eating incompatible food combinations. Day sleep except in Grishma Ritu (summer season). Eating reheated food or burnt food. Taking food articles of one taste only. Eating pishttanna (processed food prepared from rice flour). Too much liquid in a large quantity. Eating packaged food from the outside. Consuming too much sugar & sweets. Consuming too spicy sour food items |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Both |
| Details |
1.Apparently healthy individuals of age group 18-
38 years irrespective of caste, religion, gender etc.
2.Individuals not doing any kind of exercise
regularly.
3. Individuals not taking any nutritional
supplements.
4.Subjects willing to follow diet & Physical
activity. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women and lactating
mothers.
2.Who doesn’t wish to give written
consent for this study.
3.Individuals having Any kind of
major medical or Surgical Illness.
4.Individuals having any drug &
addiction history.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Progression to higher levels in different assessment scales . |
Baseline ,15 days , 30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
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 1 |
|
Date of First Enrollment (India)
|
17/01/2025 |
| 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="1"
Months="4"
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 comparative study to evaluate efficacy of Vyayama (Physical Exercise) alone Versus Vyayama with Dates Fruit (Phoenix dactylifera Linn.) as Balya Ahariya Dravya (strengthening food item) on Yuktikruta Sharira Bala (Physical Fitness) in apparently healthy individuals : An Open-label Randomized Control Trial RESEARCH QUESTION
What is the effect of Vyayama alone Vs Vyayama combined with Dates fruit (Phoenix Dactylifera Linn.) as Balya Ahariya Dravya on Yuktikruta Sharira Bala in apparently healthy individuals NULL HYPOTHESIS
There is equal efficacy of Vyayama alone Versus Vyayama with Dates fruit as Balya Ahariya Dravya on Yuktikruta Sharira Bala in apparently healthy individuals
ALTERNATE HYPOTHESIS
There is significant effect of Vyayama with Dates fruit as Balya Ahariya Dravya over Vyayama alone onYuktikruta Sharira Bala in apparently healthy individuals
|