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CTRI Number  CTRI/2020/12/029595 [Registered on: 04/12/2020] Trial Registered Prospectively
Last Modified On: 18/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   The effect of Ashwagandhadi granules (Ayurveda formulation) for health promotion 
Scientific Title of Study   A study to evaluate the effectiveness of Ashwagandhadi granules on physical performance in healthy individuals 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashitha NK 
Designation  PG Scholar Department Of Swasthavritta 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Dr Ashitha NK PG Scholar Dept Of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  8078020475  
Fax    
Email  ashithajgd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bargale Sushant Sukumar 
Designation  Assisstant Professor Dept of Swasthavritta 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Dept of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9036524877  
Fax    
Email  dr.sushant99@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bargale Sushant Sukumar 
Designation  Assisstant Professor Dept of Swasthavritta 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9036524877  
Fax    
Email  dr.sushant99@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Dept of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India 
Type of Sponsor  Private medical college 
 
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 Bargale Sushant Sukumar  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital   Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA 
9036524877

dr.sushant99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  APPARENTLY HEALTHY 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ashwagandhadi granules  20gms of ashwagandhadi granules are administered with 150ml of milk orally twice daily for 30 days 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1 Subjects of the age group of 18- 40 years irrespective of gender will be selected
2 Subjects who are not on any other dietary supplements
3 Apparently healthy subjects who are ready to sign the consent form and are interested
and willing to take Ashwagandhadi Granules
 
 
ExclusionCriteria 
Details  Pregnant women lactating women 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement of physical performance in apparently healthy individuals  18 months  
 
Secondary Outcome  
Outcome  TimePoints 
Improve the quality of life   18 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   16/12/2020 
Date of Study Completion (India) 30/04/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
1.Phyto physico chemical profile of ashwagandhadi choorna 2. Evaluation of efficacy of Ashwagandhadi granules in improving physical fitness through VO2 max(maximum oxygen comsumption) in healthy subjects. 3. A critical analysis of Ashwagandhadi granules on nutritional aspect of physical fitness. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Physical fitness is a state of health and wellbeing and more specifically the ability to perform aspects of sports, occupation and daily activities. Physical fitness is generally achieved through proper nutrition, moderate physical exercise, hygiene and sufficient rest. Among these the important modifiable factors are exercise and nutrition. Considering the nutritional aspect of physical fitness, supplements are required to bridge the gap due to faulty food habits. But in the present scenario the supplements available in the market are not meeting the required standards and many are not scientifically researched for its nutrient content. Hence there is a need for a health supplement which meets the daily requirements which is tasty health promotive and provide optimum nutrients for improving the physical fitness. Ashwagandha, Shatavari,Ragi, Mudga, Jeeraka and shunti are formulated in granules and is evaluated for its effectiveness in physical performance in healthy individuals.

This study is a comparative clinical trial where the healthy volunteers are observed for one month and the next month they will be administered with Ashwagandhadi granules for one month and then assessed for their physical performance.

This is an open labelled wait listed cross over to study the effectiveness of Ashwagandhadi granules on physical performance in apparently healthy individuals The subjects reporting at the Out Patient Department of Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan will be allocated to control group of 20 subjects and after a period of one month of observation they will be shifted to study group and will be administered with 20 gms of Ashwagandhadi granules with 150 ml of milk 
Control group: 20 subjects included in study for a period of one month and data will be collected before and after the study. The same subjects will then be shifted to study group.
Study group: 20 grams of Ashwagandhadi Granules with 150 ml of milk twice daily after food for 20 subjects included in study for a period of one month and data will be collected before and after the study. 
Conclusion- Ashwagandhadi granules increase the  physical performance

 


 
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