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CTRI Number  CTRI/2025/11/096925 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On: 08/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Ayurvedic Medicine-Saptamruta Lauha in Patients of Vitamin B12 Deficiency  
Scientific Title of Study   An Open Labelled Randomized Standard Controlled Clinical Study On Efficacy Of Saptamruta Lauha In Vitamin B12 Deficiency (Pandu) 
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 Haritkumar Sojitra 
Designation  Kayachikitsa Postgraduate Scholar 
Affiliation  G.J Patel Institute Of Ayurvedic Studies And Research 
Address  Department of Kayachikitsa,G.J Patel Institute Of Ayurvedic Studies And Research,S.G.Patel Ayurveda Hospital And Maternity Home,New V.V Nagar, Anand, Gujarat-388121 Anand GUJARAT 388121 India

Anand
GUJARAT
388121
India 
Phone  9664924404  
Fax    
Email  haritkumar.sojitra@ayugjac.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh Deole 
Designation  Professor 
Affiliation  G.J Patel Institute Of Ayurvedic Studies And Research 
Address  Department of Kayachikitsa,G.J Patel Institute Of Ayurvedic Studies And Research,S.G.Patel Ayurveda Hospital And Maternity Home,New V.V Nagar, Anand, Gujarat-388121 Anand GUJARAT 388121 India

Anand
GUJARAT
388121
India 
Phone  9974999309  
Fax    
Email  yogesh.deole@cvmu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Haritkumar Sojitra 
Designation  Kayachikitsa Postgraduate Scholar 
Affiliation  G.J Patel Institute Of Ayurvedic Studies And Research 
Address  Department of Kayachikitsa,G.J Patel Institute Of Ayurvedic Studies And Research,S.G.Patel Ayurveda Hospital And Maternity Home,New V.V Nagar, Anand, Gujarat-388121 Anand GUJARAT 388121 India

Anand
GUJARAT
388121
India 
Phone  9664924404  
Fax    
Email  haritkumar.sojitra@ayugjac.edu.in  
 
Source of Monetary or Material Support  
G.J Patel Institute Of Ayurvedic Studies and Research,Department of Kayachikitsa, New Vallabh Vidyanagar,Anand-388121 
 
Primary Sponsor  
Name  Dr Haritkumar Rajeshbhai Sojitra 
Address  Department of Kayachikitsa, G.J Patel Institute Of Ayurvedic Studies And Research, New V.V Nagar,Anand,Gujarat-388121 Anand GUJARAT 388121 
Type of Sponsor  Other [SELF] 
 
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 Haritkumar Sojitra  S.G.Patel Ayurveda Hospital And Maternity Home  Department of Kayachikitsa, G.J Patel Institute Of Ayurvedic Studies And Research, S.G.Patel Ayurveda Hospital And Maternity Home, New V.V Nagar,Anand,Gujarat-388121
Anand
GUJARAT 		 9664924404

haritkumar.sojitra@ayugjac.edu.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
G.J Patel Institute Of Ayurvedic Studies And Research & S.G. Patel Ayurveda Hospital & Maternity Home Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E538||Deficiency of other specified B group vitamins. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Mecobalamin , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1.5(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Saptamruta Lauha, Reference: Bhaishajya Ratnavali Netraroga chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Unequal quantity of Ghrita and Madhu), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Serum Vitamin B12 level below 300 Pg/DL  
 
ExclusionCriteria 
Details  1.Patient suffering from any other severe cardiac disease, advanced liver and kidney diseases,
malignancies
2.pregnant women, lactating women
3.Patients taking proton pump inhibitors, h2 blocker, metformin
Recent vitamin B12 supplementation within the past 3 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Saptamruta lauha is effective in improving serum vitamin B12 level in patients of vitamin B12 deficiency  30 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Sapatamruta Lauha is effective in improving symptoms of Vitamin B12 deficiency   30 Days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/12/2025 
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="2"
Months="0"
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   Vitamin B12 is a essential vitamin, It plays a critical role in various physiological function, including red blood cell formation, neurological function, and DNA synthesis.

Vitamin B12 also known as cobalamin, is a vital water-soluble vitamin, plays vital role in maintenance of proper neurological function through its involvement in myelin production and nerve cell metabolism. Beyond these primary roles, vitamin B12 also contributes to energy production and supports cardiovascular health by regulating homocysteine levels.

The aetiology of vitamin B12 deficiency is multifactorial, It can result from dietary insufficiency, maldigestion, malabsorption syndrome, genetic mutations impacting transport proteins like transcobalamin. “Intrinsic factor”, A glycoprotein secreted by the stomach’s parietal cells, Thus any disruption in its production or function may lead to deficiency. 
 
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