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CTRI Number  CTRI/2024/08/072570 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 16/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   An Ayurvedic drug in Fatigue.  
Scientific Title of Study   Efficacy of Shramahara Mahakashaya Granules in Labourers with Hard physical Activity W.S.R to Shrama(Fatigue)-An Open Label Single Arm Clinical 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  Manali R Patel 
Designation  2nd year MD Scholar  
Affiliation  Shree Swaminarayan Ayurvedic College, Kalol,Kalol 
Address  Post graduate department of Samhita Evum Siddhanta,Shree Swaminarayan Ayurvedic College Ahmedabad-Mehsana Highway At and po Saij Ta Kalol Dist Gandhinagar Gujarat 382725 india

Gandhinagar
GUJARAT
382725
India 
Phone  9638972757  
Fax    
Email  rpatelmanali@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemal Bhatt 
Designation  Associate professor  
Affiliation  Shree Swaminarayan Ayurvedic College,Kalol 
Address  Post graduate department of Samhita Evum Siddhanta,Shree Swaminarayan Ayurvedic College Ahmedabad-Mehsana Highway At and po Saij Ta Kalol Dist Gandhinagar Gujarat 382725 india

Gandhinagar
GUJARAT
382725
India 
Phone  9429021903  
Fax    
Email  hemalayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Manali R Patel 
Designation  2nd year MD Scholar 
Affiliation  Shree Swaminarayan Ayurvedic College,Kalol 
Address  Post graduate department of Samhita Evum Siddhanta,Shree Swaminarayan Ayurvedic College Ahmedabad-Mehsana Highway At and po Saij Ta Kalol Dist Gandhinagar Gujarat 382725 india

Gandhinagar
GUJARAT
382725
India 
Phone  9638972757  
Fax    
Email  rpatelmanali@gmail.com  
 
Source of Monetary or Material Support  
Shree Swaminarayan Ayurvedic College and Hospital Ahmedabad-Mehsana Highway At and Po.Saij Ta.Kalol Dist.Gandhinagar-382725 
 
Primary Sponsor  
Name  Premswarup Swami Ayurvedic Multi SpecialityHospital Kalo 
Address  Shree Swaminarayan Ayurvedic College Premswarupswami Ayurvedic multispeciality Hospital Ahmedabad-Mehsana Highway At and Po.Saij Ta.Kalol Dist.Gandhinagar-382725 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manali R Patel  Premswarupswami Ayurvedic Multispeciality Hospital ,Kalol  OPD-004 Samhita Evum Siddhanta Department Premswarupswami Ayurvedic Multispeciality Hospital Ahmedabad-Mehsana Highway At and Po.Saij Ta.Kalol Dist.Gandhinagar Gujarat 382725 India
Gandhinagar
GUJARAT 		 9638972757

rpatelmanali@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE Shree Swaminarayan Ayurvedic College and Hospital Kalo  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Shrama(Fatigue) 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shramahara Mahakashaya Granules, Reference: Charaka Samhita, Shadvirechana Shatashritiya Adhyaya, Sutrasthana, Route: Oral, Dosage Form: Khanda /Granules, Dose: 10(g), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age – 30-60 years Labourers (Acc to Acharya Charaka – Madhyama Avastha) irrespective of gender.
2. In the Chalder fatigue scale scoring 2 & 3 will be included. 
 
ExclusionCriteria 
Details  1. Age- ≤ 30 years and ≥ 60 years Labourers.
2. Any type of acute & chronic diseases.
3. Pregnant women and lactating mothers.
4. Any type of Coexisting diseases.
5. In the chalder fatigue scale scoring 0 & 1 will be excluded.
6. Patients who are in the Convalescence period (before minimum of 3 Month). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Shramahara Mahakashaya Granules in Shrama(Fatigue)  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
To develop an understanding of Shrama based on the principles of Ayurveda.
To develop an understanding of Fatigue according to modern science.
To study the properties and effects of Shramahara Mahakashaya Granules in Labourers with Hard physical Activity W.S.R. to Shrama(Fatigue). 		 30 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/10/2024 
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="2"
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  
I, Manali R Patel, PG Scholar, Samhita Evum Siddhanta department will try to evaluate the efficacy of Shramahara Mahakashaya Granules in Labourers with Hard physical Activity W.S.R to Shrama (fatigue). Shramahara Mahakashaya describe in charaka samhita, Shadvirechana Shatashritiya Adhyaya of Sutrasthana to reduce Shrama(Fatigue). Shrama(Fatigue) is a very common symptom that is seen in almost every person more or less in today lives. I will be evaluating the efficacy of Shramahara Mahakashaya Granules in Labourers with Hard physical Activity W.S.R. to Shrama (Fatigue). An attempt will be made to find out an easy, Palatable, most effective Granules in the Management of Shrama(Fatigue) in Labourers.
 
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