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CTRI Number  CTRI/2024/10/075940 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 25/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   To study the effect of Black raisins in underweight person for weight gain. 
Scientific Title of Study   An exploratory clinical trial to evaluate the efficacy of Mrudvika ( Vitis vinifera Linn.) as Brumhana in Krusha individuals. 
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 Simran Kankate  
Designation  PG Student 
Affiliation  PDEAs College of Ayurved and Research Centre, Nigdi , Pune  
Address  PDEAs College of Ayurved and Research Centre, 1st floor, Swasthavritta and Yoga department, Sector no 25, Pradhikaran, Nigdi, Pune

Pune
MAHARASHTRA
411044
India 
Phone  9763377332  
Fax    
Email  simukankate@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepali Manore  
Designation  Associate Professor 
Affiliation  PDEAs College of Ayurved and Research Centre, Nigdi , Pune  
Address  PDEAs College of Ayurved and Research Centre, 1st floor, Swasthavritta and Yoga department, Sector no 25, Pradhikaran, Nigdi, Pune

Pune
MAHARASHTRA
411044
India 
Phone  9881650526  
Fax    
Email  dr.manore@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Simran Kankate  
Designation  PG Student 
Affiliation  PDEAs College of Ayurved and Research Centre, Nigdi , Pune  
Address  PDEAs College of Ayurved and Research Centre, 1st floor, Swasthavritta and Yoga department, Sector no 25, Pradhikaran, Nigdi, Pune

Pune
MAHARASHTRA
411044
India 
Phone  9763377332  
Fax    
Email  simukankate@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College of Ayurved and Research Centre Nigdi Pune 411044 Maharashtra India 
 
Primary Sponsor  
Name  PDEAs College of Ayurved and Research Centre  
Address  Sector no 25 Pradhikaran Nigdi Pune 411044 
Type of Sponsor  Private medical college 
 
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 Simran Kankate  Ayurved Rugnalaya And Sterling Multispeciality Hospital   OPD no 123 B Swasthavritta Department
Pune
MAHARASHTRA 		 9763377332

simukankate@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Standard Operating Procedure for Institutional Ethical Committee-I for Human Research at Pune District Education Associations College of Ayurved and Research Centre Pune.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Volunteer with age group 18 to 30 years having BMI between 16 to 18.5 kg per meter square 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Mrudvika (Vitis vinifera Linn.), Reference: Charak Samhita Sutrasthana Chapter no 27 Annapana Vidhi Adhyaya shloka number 126, Route: Oral, Dosage Form: , Dose: 30(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -Mrudvika(Vitis vinifera Linn.)30 gm per day is given orally at morning empty stomach for 3 months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Volunteers of age group between 18 to 30 years and with BMI between 16 to 18.5 kg per meter square 
 
ExclusionCriteria 
Details  1. Volunteers Consuming protein supplement or mass gain products.
2. Volunteers having history of chronic disease like cancer, tuberculosis, endocrine dysfunctions like hyperthyroidism.
3. Pregnancy and lactation
4. Secondary cause of undernutrition 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of consumption of Mrudvika for 3 months as Brumhana in Krusha individuals  3 times 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   13/12/2024 
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="0"
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    In todays era due to improper diet people are facing many nutritional disorders, likely undernutrition and overnutrition. our ancient acharya’s mentioned various types of treatments and diets for these conditions. In Bhavaprakasha Brumhana is advised for Krusha individuals . Brumhana is the procedure to nourish tissues and improve their quality to make the body compact. Mrudvika has Madhur rasa , Madhur vipak , Sheet veerya  also it is mentioned in Madhur skanda due to this factors it has great Brumhana qualities . According to nutrition value of Indian food , Black raisins has 71.77 gms of carbohydrates , 2.77 gms Proteins , 0.36 gms fats and 1291 KJ energy per 100 gms. so this is an attempt to estimate the effect of Mrudvika as Brumhana in Krusha individuals. 
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