| CTRI Number |
CTRI/2025/02/080533 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study and compare the effects of two drugs,Yastimadhu and Ashwagandha in young patients with Easy Mental Fatiguability. |
|
Scientific Title of Study
|
Evaluation of comparative Clinical efficacy of Yastimadhu Rasayana versus Ashwagandha Rasayana in young adults with symptoms of Easy Mental Fatiguability-A Randomized control trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahima Shrivastava |
| Designation |
Ph.D. Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H), Wardha, |
| Address |
Department of Kayachikitsa Room Number 46 Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H), Wardha, 442004, Maharashtra India
Department of Kayachikitsa Room Number 46 Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H), Wardha, 442004, Maharashtra India
Wardha
MAHARASHTRA
442004
India |
| Phone |
9893569104 |
| Fax |
|
| Email |
msmahishri6878@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Saurabh Deshmukh |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H), Wardha, |
| Address |
Department of Kayachikitsa Room Number 46 Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H), Wardha, 442004, Maharashtra India
Department of Kayachikitsa Room Number 46 Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H), Wardha, 442004, Maharashtra India
Wardha
MAHARASHTRA
442004
India |
| Phone |
9403317799 |
| Fax |
|
| Email |
ayurrulz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahima Shrivastava |
| Designation |
Ph.D. Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H), Wardha |
| Address |
Department of Kayachikitsa Room Number 46 Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H), Wardha, 442004, Maharashtra India
Department of Kayachikitsa Room Number 46 Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H), Wardha, 442004, Maharashtra India
Wardha
MAHARASHTRA
442004
India |
| Phone |
9893569104 |
| Fax |
|
| Email |
msmahishri6878@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H), Wardha, 442004, Maharashtra India |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Mahima Shrivastava |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H), Wardha |
Department of Kayachikitsa Room Number 46 Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H), Wardha, 442004, Maharashtra India
Wardha
MAHARASHTRA |
9893569104
msmahishri6878@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mahatma Gandhi Ayurved College, Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R538||Other malaise and fatigue. Ayurveda Condition: GLANIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yastimadhu, Reference: Bhavprakash 6/146, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 8(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha, Reference: Bhavprakash Chapter 6(IV)/190, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 8(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients who would be ready to accept the treatment protocol guideline as per the study and would give informed consent.
All the patients of genders, male and female, of the age group 18 to 30 years, have socioeconomic status in the middle and upper class.
Patients belonging to managerial work, student, and academician as an occupation.
Patients with symptoms of easy mental fatiguability (Assessed with CIS-R score of more than 26).
Patients who are not using any kind of tonics multivitamins for improving general health. |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate in the trial.
Patients with Hb levels less than 13 gm% (male) and 9 gm% (female).
Patient with acute and chronic Metabolic, Endocrinal, and nutritional disorders.
Patients suffering from chronic debilitating diseases.
Patients with alcohol and drug abuse.
Patients with evidence of delirium, confusion, and other disturbances of consciousness, psychotropic diseases using any psychotropic drug. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mental Fatigue Scores
CFS Scores |
At the baseline (Day 0) and at the end of intervention (Day 61) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MFIS Scores ( to measure the impact of mental fatigue )
FSS Scores ( to assess the severity and frequency)
PVT-10 (to assess the overall slowing of Reponses)
Satva Scores (Ayurveda)
Dhi, Dhriti, Smriti Scores(Ayurveda)
VAS-F (subjective assessment of mental fatigue
CIS-R Scores (subjective assessment of mental fatigue ) |
At the baseline (Day 0), After one Month (Day 31) and at the end of intervention (Day 61) |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 2 |
|
Date of First Enrollment (India)
|
06/03/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The Title of the Research work: Evaluation of comparative Clinical efficacy of Yastimadhu Rasayana Versus Ashwagadha Rasayana in young adults with symptoms of Easy Mental-Fatiguability – A Randomized control trial. AIM of the Study Evaluation of comparative clinical efficacy of Yastimadhu Rasayana Versus Ashwagandha Rasayana in young adults with symptom of Easy mental Fatiguability. OBJECTIVES 1. To evaluate the efficacy of Yastimadhu Rasayana in the management of Easy mental Fatiguability on the basis of objective and subjective parameters. 2. To evaluate the efficacy of Ashwagandha Rasayana in the management of Easy mental Fatiguability on the basis of objective and subjective parameters. 3. To compare the efficacy of Yastimadhu Rasayana and Ashwagandha Rasayana in the management of Easy mental fatiguability on the basis of objective and subjective parameters. Hypothesis RESEARCH HYPOTHESIS: Alternate Hypothesis (H1) Yastimadhu Rasayana is not inferior in management of Easy mental Fatiguability when compared to Ashwagandha Rasayana. Null Hypothesis (H0) There is no difference in the efficacy of Yastimadhu Rasayana and Ashwagandha Rasayana in the management of Easy mental Fatiguability . |