| 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
|
|
|
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
|
|
|
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 |