| CTRI Number |
CTRI/2023/12/060756 [Registered on: 26/12/2023] Trial Registered Prospectively |
| Last Modified On: |
12/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Difference between effect of Ashwagandha (Withania Somnifera) and Brahmi (Bacopa monnieri Linn) on stress level and quality of sleep in patients experiencing stress. |
|
Scientific Title of Study
|
Evaluation of Comparative efficacy of Ashwagandha (Withania Somnifera) Vs Brahmi (Bacopa monnieri Linn) on stress level and quality of sleep in subjects experiencing stress. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohnish Gokhale |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College salod Wardha |
| Address |
OPD & IPD of Kayachikitsa Department Room Number 30
Datta Meghe Institute Of Higher Education And Research Mahatma Gandhi Ayurved College And Research Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8668200371 |
| Fax |
|
| Email |
mohnishgokhale76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Kuchewar |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College And Research Centre Salod Hirapur Wardha |
| Address |
OPD & IPD of Kayachikitsa Department Room Number 30
Datta Meghe Institute Of Higher Education And Research Mahatma Gandhi Ayurved College And Research Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9420998747 |
| Fax |
|
| Email |
vkuchewar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohnish Gokhale |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
OPD & IPD of Kayachikitsa Department Room Number 30
Datta Meghe Institute Of Higher Education And Research Mahatma Gandhi Ayurved College And Research Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8668200371 |
| Fax |
|
| Email |
mohnishgokhale76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatama Gandhi Ayurved College Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Mohnish Gokhale |
| Address |
OPD & IPD of Kayachikitsa Department Room Number 30
Datta Meghe Institute Of Higher Education And Research Mahatma Gandhi Ayurved College And Research Centre Salod Hirapur Wardha |
| Type of Sponsor |
Other [SELF] |
|
|
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 Mohnish Gokhale |
Mahatama Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
OPD and IPD of Department of Kayachikitsa Room No 30 Wardha
Wardha
MAHARASHTRA |
8668200371
mohnishgokhale76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital And Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F450||Somatization disorder. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Brahmi, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Ashwagandha, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Body mass index 18–29 kg/m2
2 Healthy as determined by medical history physical examination, and clinical judgment of the investigator under perceived stress with a score of 14–24 on the PSS
3 Cognitively sound as confirmed by the Montreal Cognitive Assessment test
4 Willing and able to provide written informed consent and agreed to attend regular follow-ups
5 Patients with controlled NIDDM & HTN
|
|
| ExclusionCriteria |
| Details |
1 Pregnant & lactating woman
2 Subjects with an education level below the eighth grade and unable to read
3 Subjects with any severe comorbid medical conditions or any clinically significant systemic disease with significant medication use
4 Subjects with a history of drug dependence alcohol intake or having nicotine or caffeine dependence
5 Night duty people
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lowering of stress level in patients of stress level in subjects experiencing stress |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improving of sleep quality |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2024 |
| 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="6"
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
|
This study is Double blind randomised controlled trial comparing the
clinical efficacy of Tablet Ashwagandha 500 gm HS and Tablet Brahmi 500 mg HS for 60 days in 60 patients(30 patients in each group) the primary
outcome will measure by Percieved stress scale (PSS) Montreal Cognitive assesment test Pittersberg sleep quality index (PSQI) before and after completion of treatment |