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CTRI Number  CTRI/2025/08/092582 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Elemental iron in the form of ferrous ascorbate]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Bajra (pearl millet) Laddu in reducing Iron Deficiency in Women of Reproductive Age 
Scientific Title of Study   Effect of Pearl Millet (Bajra) Laddu Consumption on Iron Deficiency Anemia in the Women of Reproductive Age Group 
Trial Acronym  nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHACHI TRIPATHI 
Designation  RESEARCH SCHOLAR 
Affiliation  BANARAS HINDU UNIVERSITY 
Address  DEPARTMENT OF PRASUTI TANTRA, FACULTY OF AYURVEDA,IMS,BANARAS HINDU UNIVERSITY,VARANASI,UTTAR PRADESH,221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  8543837773  
Fax  8543837773  
Email  shachitripathi@bhu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  SHACHI TRIPATHI 
Designation  RESEARCH SCHOLAR 
Affiliation  BANARAS HINDU UNIVERSITY 
Address  DEPARTMENT OF PRASUTI TANTRA, FACULTY OF AYURVEDA, IMS, BANARAS HINDU UNIVERSITY,VARANASI,UTTAR PRADESH,221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  8543837773  
Fax  8543837773  
Email  shachitripathi@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  SHACHI TRIPATHI 
Designation  RESEARCH SCHOLAR 
Affiliation  BANARAS HINDU UNIVERSITY 
Address  DEPARTMENT OF PRASUTI TANTRA, FACULTY OF AYURVEDA,IMS,BANARAS HINDU UNIVERSITY,VARANASI,UTTAR PRADESH,221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  8543837773  
Fax  8543837773  
Email  shachitripathi@bhu.ac.in  
 
Source of Monetary or Material Support  
Incure Expenses of Pearl Millet laddu by Research Scholar, Blood Reports Expenses by Patient and Nutritional analysis of Pearl Millet Laddu will be funded by SRICC,BHU. 
 
Primary Sponsor  
Name  BANARAS HINDU UNIVERSITY 
Address  BANARAS HINDU UNIVERSITY, VARANASI,UTTAR PRADESH,221005 
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 Shikha Singh  Banaras Hindu University  Department of Prasuti Tantra and Kayachikitsa, Faculty of Ayurveda,IMS, BHU,Varanasi,U.P.,221005
Varanasi
UTTAR PRADESH 		 9453663997
9453663997
shikha.singh357@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Banaras Hindu University IMS INSTITUTIONAL ETHICS COMMITTEE VARANASI 221005  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E638||Other specified nutritional deficiencies. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Pearl Millet Laddu, Reference: research artical, Route: Oral, Dosage Form: Gudpak, Dose: 75(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lemon water), Additional Information: -
2Comparator Arm (Non Ayurveda)-Elemental IronElemental iron in the form of Ferrous Ascorbate 30 ml BID to the control group
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Patients with signs and symptoms of Iron deficiency Anemia whose hemoglobin
levels ranging from 7.0 gm/dL to 10 gm/dL will be included.
This study will include female patients aged between 15 to 49years.
Patients will be enrolled irrespective of religion, occupation, and socioeconomic background
If MCW (mean corpuscular volume) below 80fl.
If MCH (mean corpuscular hemoglobin)is below 25pg. 
 
ExclusionCriteria 
Details  Patients not willing to participate in the study will be excluded.
Those who have any other type of anemia such as thalassemia, sickle cell anemia, and severe (hb-below 7 g/dl) nutritional anemia.
Diseases suffering from any chronic disease like aids, cancer, TB, Rheumatoid arthritis, Renal disease, Diabetes Miletus, Heart disease, Hypertension, Inflammatory Disease, Infectious Disease, etc.
Pregnant women will be excluded.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
We Expect That Pearl Millet(Bajra) Laddu will cure The Patients Suffering From
Iron Deficiency Anemia. 		 The Period of This Intervention will be 45 Days. 
 
Secondary Outcome  
Outcome  TimePoints 
We expect that Pearl millet laddu will be helpfull in women Reproductive health as well as Overall wellbeing.  The Period of This Intervention will be 45 Days. 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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   N/A 
Date of First Enrollment (India)   01/10/2025 
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 Yet Recruiting 
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 study will be conducted in the OPD and IPD of Prasuti Tantra Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi. After registration, the patient will be checked for Iron deficiency Anemia using the CBC and other blood tests. Patients with signs and symptoms of Iron deficiency Anemia whose hemoglobin levels ranged from 7.0 gm/dL to 10 gm/dL will be included. This study will include female patients aged between 15 to 49years. Patients will be enrolled irrespective of religion, occupation, and socioeconomic background. If MCV (Mean Corpuscular Volume) is Below 80 fl and MCH(Mean Corpuscular Hemoglobin) is below 25 pg. Patients not willing to participate in the study will be excluded. Those who have any other type of anemia such as thalassemia, sickle cell anemia, and severe [Hb-<7.0 g/dl] nutritional anemia. Diseases Suffering from any Chronic disease like AIDS, Cancer, Tuberculosis, Rheumatoid arthritis, Renal disease, Diabetes Miletus, Heart Disease, Hypertension, inflammatory disease, infectious disease, etc. Pregnant women will be excluded. Once confirmed, the patient will be provided with Pearl millet laddu. Post-intervention tests will be conducted 45 days after the intervention. Written consent will be taken from the patient participating in the study.
 
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