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CTRI Number  CTRI/2025/02/081220 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Amalaki Churna As a food Supplement. 
Scientific Title of Study   To Study the Effect of Amalaki Churna As a Food Supplement In Addition to Normal Diet In Young 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 Lavika Bhatt 
Designation  Pg scholar 
Affiliation  Banaras Hindu University 
Address  Department of Kriya Sharir faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh 221005 India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9557756268  
Fax    
Email  lavika9365@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Narendra Shanker Tripathi 
Designation  Associate Professor  
Affiliation  Banaras Hindu University 
Address  Department of Kriya Sharir faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh 221005 India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9452827846  
Fax    
Email  drnstripathi@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Lavika Bhatt 
Designation  Pg scholar 
Affiliation  Banaras Hindu University 
Address  Department of Kriya Sharir faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh 221005 India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9557756268  
Fax    
Email  lavika9365@gmail.com  
 
Source of Monetary or Material Support  
Banaras Hindu university Varanasi 221005 
 
Primary Sponsor  
Name  Department of Kriya Sharir Faculty of Ayurveda IMS BHU varanasi Uttar Pradesh 
Address  Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 India 
Type of Sponsor  Government 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 Lavika Bhatt  Banaras Hindu University Varanasi  Department of Kriya Sharir faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH 		 9557756268

lavika9365@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee Banaras Hindu University Institue of Medical Sciences Varanasi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Human Volunteers heaving hemoglobin level between 8gm/dl to 11.9 gm/dl 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Amalaki churna, Reference: P.V Sharma, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -
2Comparator ArmLifestyle--Dinacarya: routine normal life style, Ritucarya: routine normal life style, Acara Rasayana:routine normal life style, Other:, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Individual heaving Hemoglobin level between 8gm/dl to 11.9gm/dl.
individuals willing to be the part of study, written consent in prescribed format. 
 
ExclusionCriteria 
Details  Volunteers having hemoglobin less than 8gm/dl
Individuals heaving Age less than 18 years and more than 35 years
Volunteers suffering from systemic diseases like Diabetes mellitus (DM), renal disorders, heart disease, cancer, acquired immune-deficiency syndrome, tuberculosis, hypertension, or any other chronic disease, pregnant and lactating females.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pallor (Panduta)
Generalised weakness (Daurbalya)
Anorexia (Aruchi)
Fatigue (Shrama)
Giddiness (Bhrama)
 		 The assessment of volunteers will be done before (baseline) and after the 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1 .Hb%
2 .RBC COUNT
3 .Mean corpuscular volume (MCV)
4 .Mean corpuscular haemoglobin (MCH)
5. Mean corpuscular haemoglobin concentration (MCHC)
 		 The assessment of volunteers will be done baseline & after 12 weeks. 
 
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 1/ Phase 2 
Date of First Enrollment (India)   01/03/2025 
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="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 open label trial to determine the effect of Amalaki Churna as a food supplement in addition to normal diet in young individuals for the age of 18 years to 35 years for 90 days. Study will be conducted at IMS BHU Varanasi on 60 individuals. Assessment will be done on the basis of subjective and objective parameters. The assignment will be done Before and After the trial . Result obtained will be tabulated and  statistically analyzed using appropriate tests. Study will be concluded on the basis of result obtained and discussion. 
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