| CTRI Number |
CTRI/2025/10/095804 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying the nutritional value of Shramahara Mahakashaya granules and checking how well they help reduce weakness and tiredness in working women |
|
Scientific Title of Study
|
Nutritional analysis of Shramahara Mahakashaya granules and its efficacy in the management of General Debility Syndrome among working women - A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Padmaja Prashant Wanjari |
| Designation |
PG Scholar |
| Affiliation |
Research Institution and Hospital |
| Address |
Room no 30 Department of Samhita Siddhant Mahatma Gandhi
Ayurved College hospital and Research Centre Salod H Wardha
442001 Maharashtra
Department of Samhita Siddhant Panini lab
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9610332268 |
| Fax |
|
| Email |
padmajawanjari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dnyanesh Joshi |
| Designation |
Professor |
| Affiliation |
Research Institution and Hospital |
| Address |
Room no 21 Department of Samhita Siddhant Mahatma Gandhi
Ayurved College Hospital and Research Centre Salod Wardha
442001 Maharashtra
Department of Samhita Siddhant Panini lab
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8087374390 |
| Fax |
|
| Email |
dnyanesh.joshi@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Padmaja Prashant Wanjari |
| Designation |
PG Scholar |
| Affiliation |
Research Institution and Hospital |
| Address |
Room no 30 Department of Samhita Siddhant Mahatma Gandhi
Ayurved College and Research Centre Salod Wardha 442001
Maharashtra
Department of Samhita Siddhant Panini lab
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9610332268 |
| Fax |
|
| Email |
padmajawanjari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha Maharashtra India 442001 |
|
|
Primary Sponsor
|
| Name |
Padmaja Prashant Wanjari |
| Address |
Department of Samhita Siddhant Mahatma Gandhi Ayurved College
and Research Centre Salod Wardha Maharshtra India 442001
|
| 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 Padmaja Wanjari |
Mahatma Gandhi Ayurved College Hospital and Research Centre Wardha Maharashtra |
Department of
Kayachikitsa
Wardha
MAHARASHTRA 442001
Wardha
MAHARASHTRA |
9610332268
padmajawanjari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mahatma Gandhi Ayurveda college Research Centre Wardha State Maharashtra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
General Debility Syndrome |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shramahara Mahakashaya, Reference: Charak Samhita Sutra sthan 4/16, Route: Oral, Dosage Form: Khanda /Granules, Dose: 15(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Female participants aged 25 to 45 years working in any occupation
Mild to Moderate fatigue with FAS score less than 36
Participants willing to participate and give written informed consent |
|
| ExclusionCriteria |
| Details |
Women with diagnosed chronic illnesses such as diabetes mellitus, hypertension, thyroid disorders, cardiovascular diseases, chronic fatigue syndrome or autoimmune disorders
Participants currently taking nutritional supplements energy boosters or herbal formulations that may interfere with fatigue assessment
Women with psychiatric conditions such as depression, anxiety disorders or sleep disorders currently under treatment
Women who are pregnant or lactating
Women with a history of substance abuse
Participants who are unable to comply with the study protocol or follow-up visits |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determination of Nutritional Composition of Shramahara Mahakashya Granules |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of Shramahara Mahakshaya Granules in General Debility Syndrome in Working Women |
2 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="1"
Months="10"
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
|
The volunteers will be informed about the study protocol. Willing participants will be selected. Clinical research format will be prepared and validated.
Prior to the study, approval will be taken from IEC, MGACHRC, Salod (H), Wardha and CTRI
registration will be done. After selection, each participant will be assessed individually and selected
according to the selection criteria. The study will be carried over a period of 14 days, which will include the treatment period as well as follow ups. Data will be collected and analized accordingly. |