| CTRI Number |
CTRI/2024/06/069402 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the Efficacy and Safety of Ashwagandha DSTR Capsule in patients with Moderate Stress Mild Anxiety Depression Low Stamina and Strength |
|
Scientific Title of Study
|
A Prospective Interventional Open label Single centre Single arm Study to Evaluate the Efficacy and Safety of Ashwagandha DSTR Capsule in Subject with Moderate Stress Mild Anxiety Depression Low Stamina and Strength |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 008/ACRS/DSTR/2024 V 1.0 dated 01 APR 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhushan Chowdhary |
| Designation |
MBBS MD Psychiatry |
| Affiliation |
Eras Bharti Hospital |
| Address |
Psychology Department Room No 3 Psychiatry division Ganesham Commercial A building 1st 3rd 4th Floor Nashik Phata Road Near Govind Yashada Chowk Sai Nagar Park Pimple Gurav Pimpri-Chinchwad 411027
Pune
Pune
MAHARASHTRA
411027
India |
| Phone |
8805720217 |
| Fax |
- |
| Email |
drbhushan_chaudhari@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Chandu Devanpally |
| Designation |
Founder & Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
office no 302 303 level-3 nyati unitree building yerwada
Pune
MAHARASHTRA
411006
India |
| Phone |
9545817447 |
| Fax |
- |
| Email |
cdevanpally@ardent-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Chandu Devanpally |
| Designation |
Founder & Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
office no 302 303 level-3 nyati unitree building yerwada
Pune
MAHARASHTRA
411006
India |
| Phone |
9545817447 |
| Fax |
- |
| Email |
cdevanpally@ardent-cro.com |
|
|
Source of Monetary or Material Support
|
| Ardent Clinical Research Services office no 302 303 level 3 Nyati unitree building pune nagar highway yerwada 411006 Pune INDIA |
|
|
Primary Sponsor
|
| Name |
M/s Synthite Industries Private Limited |
| Address |
Synthite Corporate House VIII 683-A Kadayiruppu Kolenchery Ernakulam Kerala 682 311 INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Bhushan Chaudhari |
Eras Bharti Hospital |
Dapartment of Psychology Room no 3 Psychiatry division Ganesham Commercial A building 1st 3rd & 4th Floor Nashik Phata Road Near Govind Yashada Chowk Sai Nagar Park Pimple Gurav Pimpri-Chinchwad 411027
Pune
MAHARASHTRA |
8805720217
-
Drbhushan_chaudhari@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sai Krupa Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F430||Acute stress reaction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandha DSTR Capsules along with soc |
Patient will be asked to consume 2 capsule once daily after dinner for total of 12 weeks duration along with SOC |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Include both male and female, age between 18-60 years.
2.Score on the 10-item Perceived Stress Scale (PSS) ranging from 14 to 26 at the time of screening.
3.Free of psychiatric conditions other than stress, anxiety, mild to moderate depression and cognitive deficits in moderately stressed subjects as per the discretion of the Investigator.
4.Self-reported moderate stress, mild anxiety, or depression
5.Willing and able to provide written informed consent prior to performing study procedures.
6.Participants experiencing reduced stamina and strength, as assessed by subjective reporting.
7.Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use contraceptive methods.
8. Subjects willing to comply with the protocol requirements. |
|
| ExclusionCriteria |
| Details |
1.Suffering from any chronic physical, hormonal or psychiatric illness.
2.Currently taking any herbal preparations or formulations for stress management (containing Ashwagandha, ginseng, ginkgo biloba, Brahmi or related herbs).
3.Drug abuse or aberrant laboratory findings during the screening. Medical history of clinically diagnosed severe depression, psychiatric disorder.
4.Currently taking mood stabilizer, anti-psychotic, anti-convulsion or any opioid –based analgesics.
5.Allergy or sensitivity to any of the ingredients in the study treatment.
6.Subjects with serious, critical illness, or severe mental illness.
7.Any other condition, which the Principal Investigator thinks, may jeopardize the study.
8.Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) related illness and/or known history of Hepatitis B virus (HBV), defined by presence of hepatitis B surface antigen (HBsAg) and/or known history of Hepatitis C virus (HCV), defined by presence of hepatitis C antibody (HCVAb).
9.Pregnant or lactating women.
10.Taking any of the following classes of medications: benzodiazepines, central nervous system depressants, immune suppressors, cardiovascular medication. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 Evaluate efficacy of Ashwagandha in terms of decrease in score of Perceived Stress Scale (PSS) |
1 from Screening visit to End of treatment (week 12) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Depression anxiety and stress as measured by decrease in score of Depression and Anxiety Stress Scale 21
2 Evaluate efficacy of Ashwagandha in terms of decrease in score of Hamilton- Anxiety
3 Improvement in Work Productivity and Activity Impairment Questionnaire
4 Increase in the WHO-5 Well-Being Score
5 Improvement in International Physical Activity Questionnaire |
1 from Baseline visit to End of treatment (week 12)
2 from Baseline visit to End of treatment (week 12)
3 from Baseline visit to End of treatment (week 12)
4 from Baseline visit to End of treatment (week 12)
5 from Baseline visit to End of treatment (week 12) |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A Prospective, Single centre, open label, single Arm Non-Comparative Study. For the primary endpoint (PSS), assuming an effect size of 0.55 will be attained during the study, the estimated number of subjects to be enrolled are 28 that can provide the desired effect with 95% confidence and 80% power of paired t-test. Informed consent will be obtained from the patients before enrolling in the study. The screening period will be -7 days. All 25 enrolled participants will receive the investigational product Ashwagandha DSTR Capsule along with SoC throughout the study duration. Patients’ eligibility will be confirmed based on their medical history. Eligible patients then will be enrolled in single arm. Treatment will be given to patients for 12 weeks and One week followed by End of treatment. |