| CTRI Number |
CTRI/2020/02/023321 [Registered on: 13/02/2020] Trial Registered Prospectively |
| Last Modified On: |
24/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
This study will be conducted in healthy adults with stress and anxiety, the effect as well as safety of Ashwagandha will be assessed in improving their quality of life. |
|
Scientific Title of Study
|
A study to evaluate efficacy and safety of Ashwagandha in improving quality of life in healthy adults with stress & anxiety. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CPL/83/ASH_STRS/I/AUG/19,V3.0,05-FEB-21 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Vikneswaran G |
| Designation |
Clinical Research Consultant |
| Affiliation |
Narayana Health |
| Address |
Room No. 258/A, Hosur Road, Bommasandra Industrial Area, Anekal Taluk, Bangalore.
Bangalore
KARNATAKA
560099
India |
| Phone |
09787649182 |
| Fax |
|
| Email |
vikneswaran.g.dr@narayanahealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpesh Shah |
| Designation |
Senior Vice President |
| Affiliation |
ClinWorld Private Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore.
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
kalpesh@clinworld.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpesh Shah |
| Designation |
Senior Vice President |
| Affiliation |
ClinWorld Private Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore.
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
kalpesh@clinworld.org |
|
|
Source of Monetary or Material Support
|
| Sami Labs Limited. 19/1 & 19/2,I Main,II Phase,Peenya Industrial Area,Bangalore, Karnataka. 560058. |
|
|
Primary Sponsor
|
| Name |
Sami Labs Limited |
| Address |
19/1 & 19/2,I Main,II Phase, Peenya Industrial Area, Bangalore,Karnataka.560058. |
| Type of Sponsor |
Other [Manufactures and markets phutonutrients, standardized herbal extracts and nutritional supplements.] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vikneswaran G |
Narayana Health |
Room No. 258/A, Hosur Road, Bommasandra Industrial Area, Anekal Taluk, Bangalore.560099.
Bangalore
KARNATAKA |
09787649182
vikneswaran.g.dr@narayanahealth.org |
| Dr S V Krishna Reddy |
Vijaya Super Speciality Hospital |
DRoom No. 2, Department of Urology, Raghava Cine Complex road,
Pogathota,
SPSR-Nellore,
Andhra Pradesh.524 001.
Nellore
ANDHRA PRADESH |
09849048222
svkkrishnareddy.vijaya@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Narayana Health Medical Ethics Committee |
Approved |
| Vijaya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With chronic fatigue, stress and anxiety |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo (Microcrystalline cellulose) |
One capsule once a day before bedtime for 60 days. |
| Intervention |
Shagandha |
One capsule once a day before bedtime for 60 days. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
54.00 Year(s) |
| Gender |
Both |
| Details |
1 Male and female healthy adults 21 to 54 years old.
2 Body Mass Index (BMI) in the range of 18 to 32 kg/m2.
3 Subjects free of any psychological or psychiatric conditions except stress & anxiety.
4 Adults with perceived stress scale score less than 25 and more than 14.
5 Adults complaining with anxiety,fatigue,loss of appetite,Insomnia and loss of concentration.
6 Subject must be willing and able to adhere to the assessments,visit schedules,
prohibitions and restrictions,as described in this protocol.
7 Willing to sign informed consent. |
|
| ExclusionCriteria |
| Details |
1 Pregnant and lactating female or female having the intention to be pregnant within next
three months.
2 Education level below 8th grade of schooling.
3 Unable to read or understand English or having no working knowledge of English.
4 History of alcohol abuse, excessive smoking with more than 5 cigarettes a day.
5 Established/ diagnosed neurological or psychiatric disorders.
6 With chronic gastrointestinal diseases, severe immune deficiency.
7 Lipid profile, haematological parameters, Glycaemic parameters above normal limits.
8 History of intake of ANY Ayurvedic/herbal/homeopathic/ dietary supplements
(including Vitamin E) or any alternative therapies in the last one month.
9 History of bone marrow disorders.
10 Acute medical/surgical complications which require hospitalization.
11 Subjects with history of clinically significant thyroid disorder (hypo or hyper),
cardiovascular, haematological,hepatic (SGOT or SGPT levels>2 Upper Limit of
Normal),renal (serum creatinine≥1.3 mg/dl), respiratory,or genitourinary
abnormalities or diseases.
12 A history of significant multiple and/or severe allergies or anaphylactic reactions.
13 Subjects with known history of hypersensitivity to the investigational product.
14. Subject has participated in any clinical trial within last 3 months.
15. Any other condition which the Principal Investigator thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Change in CANTAB score
2 Change in PSS scale
3 Change in WHOQOL-BREF |
1 CANTAB score(Day0 & Day60)
2 PSS scale(Screening,Day30 & Day60)
3 WHOQOL-BREF(Day0 & Day60) |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1 Change in Generalized Anxiety Disorder - 7 item scale.
2 Change in Salivary cortisol.
3 Change in Urine Serotonin and Dopamine.
4 Change in Anti oxidant stress biomarkers - Nitric oxide,Glutathione and Malondialdehyde.
5 Change in Laboratory parameters.
6 Safety of IP determined upon occurrence of Adverse events. |
1 Generalized Anxiety Disorder - 7 item scale (Screening,Day30 & Day60).
2 Salivary cortisol(Day0 & Day60).
3 Urine Serotonin and Dopamine (Day0 & Day60).
4 Anti oxidant stress biomarkers(Day0 & Day60).
5 Laboratory parameters(Screening, Day30 & Day60).
6 Adverse events(Day30,Day60 & telephonic follow up after 15 days). |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/02/2020 |
| 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="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not published yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this study is to assess the efficacy and safety of Ashwagandha in adults with chronic fatigue, stress and anxiety. After obtaining informed consent in the language best understood by the patient, they will be screened as per the inclusion criteria and those fulfilling the criteria will be enrolled in the study. Subject’s would be randomized into two groups, one group will receive Shagandha 500 mg once a day before bedtime for 60 days, while the other group will receive Placebo 500 mg once a day before bedtime for 60 days. The primary endpoints would be change in CABTAB score, PSS Score and Quality of Life from Baseline to Final visit. The secondary endpoints would be change in Generalized anxiety disorder - 7 item scale, Salivary cortisol, Urine Serotonin and dopamine, antioxidant stress markers and laboratory parameters. Adverse events would be assessed throughout the study. Appropriate statistical analysis would be applied to the data outcomes and discussion and conclusion will be made accordingly. |