| CTRI Number |
CTRI/2024/12/077984 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of ashwagandha in stress and anxiety in healthy adults |
|
Scientific Title of Study
|
Role of Ashwagandha Root Extract (ARE) in Stress and Anxiety in Healthy Adults: A Prospective, Randomized, Double-Blind, Three-arm, Parallel, Placebo-Controlled Study |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KSM-1058-2024-01,Version 1; dt. 18thJune 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRajesh Yashwant Patil |
| Designation |
Principle investigator |
| Affiliation |
Gautami Nursing Home |
| Address |
Gautami Nursing Home, Ground Floor, OPD no. 1, Jain Mandir Compound, Opp. Mumbra Police Station, Mumbra, Thane
Thane
MAHARASHTRA
400612
India |
| Phone |
9322241484 |
| Fax |
|
| Email |
dr.rypatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRajesh Yashwant Patil |
| Designation |
Principle investigator |
| Affiliation |
Gautami Nursing Home |
| Address |
Gautami Nursing Home, Ground Floor, OPD no. 1, Jain Mandir Compound, Opp. Mumbra Police Station, Mumbra, Thane
MAHARASHTRA
400612
India |
| Phone |
9322241484 |
| Fax |
|
| Email |
dr.rypatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRajesh Yashwant Patil |
| Designation |
Principle investigator |
| Affiliation |
Gautami Nursing Home |
| Address |
Gautami Nursing Home,Ground floor, OPD no. 1, Jain Mandir Compound, Opp. Mumbra Police Station, Mumbra, Thane
MAHARASHTRA
400612
India |
| Phone |
9322241484 |
| Fax |
|
| Email |
dr.rypatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ixoreal Biomed Private Limited, 5-9-225, Sanali Estate, Abids, Hydrabad-500001, ph: (91)40-23204385/86/87 India |
|
|
Primary Sponsor
|
| Name |
Ixoreal Biomed Private Limited |
| Address |
5-9-225, Sanali Estate, Abids, Hydrabad-500001 ph:(91)40-23204385/86/87 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 Rajesh Yashwant Patil |
Gautami Nursing Home |
Gautami Nursing Home,Ground floor,OPD no.1, Jain Mandir Compound, Opp. Mumbra Police Station, Mumbra, Thane
Thane
MAHARASHTRA |
09322241484
dr.rypatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male and female aged between 18 to 65 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandha root extract (125mg) |
Consume Capsule containing Ashwagandha root extract (125mg) orally twice daily after breakfast and dinner (at bedtime, with a glass of water or milk) |
| Intervention |
Ashwagandha root extract (300mg) |
Consume Capsule containing Ashwagandha root extract (300 mg) orally twice daily after breakfast and dinner (at bedtime, with a glass of water or milk) |
| Comparator Agent |
placebo capsule containing starch (300mg) |
Consume placebo capsule containing starch (300mg) orally twice daily after breakfast and dinner (at bedtime, with a glass of water or milk) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults (male and female) aged between 18 and 65 years.
2.Experiencing signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).
3.Participants with a Perceived Stress Scale (PSS) score ≥13 and without any other psychiatric conditions.
4.BMI between 20 and 35 kg/m2.
5.No plan to commence new treatments over the study period.
6. Medication-free (any medications are known to affect stress and anxiety) for at least 4 weeks. Use of analgesics (once a week) or contraceptive pills will be permissible.
7.Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
|
|
| ExclusionCriteria |
| Details |
1.Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, antipsychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening.
2.Patients currently (or within the past 4 weeks prior to screening) taking any over-the-counter use of herbal extracts such as Ginkgo Biloba, St. John’s Wort, Omega-3, etc.
3.Patients with a depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia, and mania.
4.Patients with known post-traumatic stress disorder (PTSD) and Generalized Anxiety Disorder (GAD).
5.Patients who have an established practice of meditation and relaxation techniques for three or more months.
6.Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
7.Patients with a history of alcohol, tobacco dependence, or any substance abuse.
8.Pregnant and lactating women or suspected to be pregnant.
9. Patients with known hypersensitivity to Ashwagandha.
10. Patients who had participated in other clinical trials during the previous 3 months.
11. Patients who have any clinical condition, according to the investigator, do not allow safe fulfilment of clinical trial protocol.
12. Participants having any chronic physical, haematological, hormonal, or psychiatric illness and history of substance dependence.
13.Participant taking any other herbal preparations containing Ginseng, Brahmi, Gingko Biloba or similar herbs will not be considered for participation in this study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean change in score for
Profile of Mood States (POMS, abbreviated version) questionnaire and Patient Reported Outcomes Measurement Information System (PROMIS-29) questionnaire from baseline. |
Baseline, Week 4, Week 8, Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in scores for Perceived Stress Scale (PSS) questionnaire from baseline. |
Baseline, Week 4, Week 8, Week12 |
| Mean change in scores for Oxford Happiness Questionnaire (OHQ) questionnaire from baseline. |
Baseline, Week 4, Week 8, Week 12 |
| • Mean change in scores for Pittsburgh Sleep Quality Index (PSQI) questionnaire from baseline. |
Baseline, Week 4, Week 8, Week 12 |
| Mean change in stress hormone (Sr. cortisol) from baseline. |
Baseline, Week 12 |
| Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline. |
Baseline, Week 12 |
| Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baseline. |
Baseline, Week 12 |
| Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks. |
Baseline, Week 4, Week 8, Week 12 |
| Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeks |
Baseline, Week 4, Week 8, Week 12 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
21/12/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
•All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. •Subjects will be informed about the purpose of the study and signed informed consent will be taken. •Blood sampling for efficacy and safety parameters will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1) and visit 4 (week 12). •All subjects will be followed-up during the study period (visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 4) ± 4 days, visit 3 (week 8) ± 4 days, and visit 4 (week 12) ± 4 days. •The Adverse events, either spontaneously reported by the patient, or noticed by the clinician will be recorded during the study. |