| CTRI Number |
CTRI/2022/01/039548 [Registered on: 18/01/2022] Trial Registered Prospectively |
| Last Modified On: |
07/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study to
Evaluate the Efficacy and Safety of Ashwagandha Extract Formulation on Improvement of Energy and Endurance in Adults
|
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha Extract Formulation
(ASVAMAN®) on Improvement of Energy and Endurance in Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MN/EE/1121, Version 1.0 Dated 25 November 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gaurav Singh |
| Designation |
MD - General Medicine |
| Affiliation |
Vatsalya Hospital |
| Address |
Department of General Medicine, Room no 2 Ground Floor S2 656C 4A Sikraul
S2 656C 4A Sikraul
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9555112643 |
| Fax |
|
| Email |
drgauravsingh371@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr HN Shivaprasad |
| Designation |
Managing Director |
| Affiliation |
Manipal Natural Private Limited |
| Address |
N-301,3rd Floor, Manipal Centre, North Block,
Dickenson Rd, Bengaluru,
Bangalore Rural
KARNATAKA
560042
India |
| Phone |
8971489704 |
| Fax |
|
| Email |
shiv@manipalnatural.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Manohar Divanji Shriranga |
| Designation |
Manager- R&D |
| Affiliation |
Manipal Natural Private Limited |
| Address |
N-301,3rd Floor, Manipal Centre, North Block,
Dickenson Rd, Bengaluru
Bangalore Rural
KARNATAKA
560042
India |
| Phone |
|
| Fax |
|
| Email |
manohar.d@manipalnatural.com |
|
|
Source of Monetary or Material Support
|
| Manipal Natural Private Limited
N-301,3rd Floor, Manipal Centre, North Block,
Dickenson Rd, Bengaluru,
Karnataka 560042 |
|
|
Primary Sponsor
|
| Name |
Manipal Natural Private Limited |
| Address |
N-301,3rd Floor, Manipal Centre, North Block, Dickenson Rd, Bengaluru, Karnataka 560042 |
| Type of Sponsor |
Other [Nutraceutical] |
|
|
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 Gaurav Singh |
Vatsalya Hospital |
Room no 2 Ground Floor S2 656C 4A Sikraul
Varanasi
UTTAR PRADESH |
0542-2281750
gaurav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vatsalya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Energy and Endurance |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Asvaman, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: Two capsules (300 mg) daily one in the morning and one in the evening after meal for 42 days | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: Two capsules (300 mg) daily one in the morning and one in the evening after meal for 42 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Male healthy adult subjects ranging in age from 18 to 50 years.
2. Willingness to follow the protocol requirements as evidenced by written,
informed consent.
3. Mentally, physically and legally eligible to give informed consent
4. Male subjects BMI between 20.0 – 25.9 kg/m2
5. Willingness to complete study questionnaires. |
|
| ExclusionCriteria |
| Details |
1. Patients with pre-existing severe systemic disease necessitating long-term medication.
2. Significant medical or psychiatric illness
3. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ
4. Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments
5. Participation in the current or previous treatment with any approved or investigational health supplement(s) during the past 1 month.
6. Subjects received other medication (anti-viral) within the 36 hours before entry into the study
7. Patients who had immunization against influenza or influenza like illnesses for that season.
8. Inability to comply with the study protocol, including psychiatric diseases.
9. Immune compromised or with other clinically active illness including cardiac or pulmonary diseases, hemoglobinopathies, renal dysfunction
10. Having vaccination of a seasonal or new influenza A (H1N1) vaccine 6 months before.
11. Other reasons that researchers think not fitting to participate in the study
12. Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation.
13. Patient tested positive with Covid 19 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to the end of the study period in Serum Cortisol |
Day 0 and Day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to the end of the study period in Six Minutes’ walk test |
Day 0, Day 21 and Day 42 |
| Change from baseline to the end of the study period in One Leg Stand Test |
Day 0, Day 21 and Day 42 |
| Change from baseline to the end of the study period in Stair Climb Test |
Day 0, Day 21 and Day 42 |
| Change from baseline to the end of the study period in 30 Meter walk test |
Day 0, Day 21 and Day 42 |
| Change from baseline to the end of the study period in Chair Stand Test |
Day 0, Day 21 and Day 42 |
| Change from baseline to the end of the study period in Quality of Life – SF 36 |
Day 0, Day 21 and Day 42 |
| Change from baseline to the end of the study period in Testosterone |
Day 0 and Day 42 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/01/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha Extract Formulation (ASVAMAN®) on Improvement of Energy and Endurance in Adults |