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CTRI Number  CTRI/2026/01/100488 [Registered on: 07/01/2026] Trial Registered Prospectively
Last Modified On: 05/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A community study of Drakshvaleha on Anaemia 
Scientific Title of Study   A community-based study on the effectiveness and acceptance of Drakshavaleha for anaemia in selected districts of the Vidarbha region, Maharashtra 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kalpana Kachare 
Designation  Research Officer (Ayurveda) 
Affiliation  Central Council for Research in Ayurvedic Sciences 
Address  Central Council for Research in Ayurvedic Sciences, Room No 121, 61-65, Institutional area, Opposite to D" Block , Janakpuri, New Delhi

New Delhi
DELHI
110058
India 
Phone  09834410028  
Fax    
Email  kachare.kalpana@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kalpana Kachare 
Designation  Research Officer (Ayurveda) 
Affiliation  Central Council for Research in Ayurvedic Sciences 
Address  Central Council for Research in Ayurvedic Sciences, Room No 121, 61-65, Institutional area, Opposite to D" Block , Janakpuri, New Delhi

New Delhi
DELHI
110058
India 
Phone  09834410028  
Fax    
Email  kachare.kalpana@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kalpana Kachare 
Designation  Research Officer (Ayurveda) 
Affiliation  Central Council for Research in Ayurvedic Sciences 
Address  Central Council for Research in Ayurvedic Sciences, Room No 121, 61-65, Institutional area, Opposite to D" Block , Janakpuri, New Delhi

New Delhi
DELHI
110058
India 
Phone  09834410028  
Fax    
Email  kachare.kalpana@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, under Ministry of Ayush, New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, 61-65, Oppos. to D Block, Institutional Area Janakpuri-110058, New Delhi 
Type of Sponsor  Research institution 
 
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 Pargaonkar Akshay Sudhir  Datta Meghe Institute of Higher Education & Research (DMIHER), Wardha  Assistant Professor, Department of dravyguna, Mahatma Gandhi Ayrveda Collage, Swangi – Meghe –442001, Wardha, Maharshtra, India
Wardha
MAHARASHTRA 
8975517283

akshay.pargaonkar@dmiher.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D649||Anemia, unspecified. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Drakshavaleha, Reference: AFI, Part -I, 3:15, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: -
(2) Medicine Name: Krimimudgar Rasa , Reference: API Part-2, Vol-2, p.no. 71, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  i) Individuals of any gender, age above 18 years
ii) Hb 8-11.9 in women and 8-12.9 in men
iii) Willing to take the Ayurveda intervention for 3 months
 
 
ExclusionCriteria 
Details  1. Pregnant women
2. Known cases of Diabetes mellitus
3. Known cases of any Hemoglobinopathies, bleeding disorders, serious systemic illnesses like malignancy,
4. Individuals having a family history of hemoglobinopathies and history of blood transfusion in the last 6 months
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in mean haemoglobin levels from baseline to the end of 12th weeks  At the end of 12th weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in mean score of the FACIT-Fatigue Scale from baseline to the end of 12 weeks   At the end of 12th weeks 
Proportion of participants showing treatment adherence equal to and more than 70%  At the end of 4th,8th & 12th weeks 
Participant satisfaction with intervention (measured through end-line interview)  At the end of 12th weeks 
Proportion of men with Hb gm% equal or more than 13 and women with Hb gm % equal or more than 12 after three months of Ayurveda intervention  At the end of 12th weeks 
 
Target Sample Size   Total Sample Size="8300"
Sample Size from India="8300" 
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 3 
Date of First Enrollment (India)   11/01/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Anaemia, defined as a reduction in the haemoglobin concentration of the blood, is a widespread public health issue, particularly in developing countries. In India, anaemia continues to be a major concern, affecting children, adolescents, and adults. It leads to fatigue, poor work performance, impaired cognitive and physical development, and, in severe cases, can result in maternal and perinatal mortality. Anaemia is classified as being mild, moderate or severe based on the extent of haemoglobin deficiency. The majority of anaemia in India is categorised as mild or moderate, with under 3 percent of women and children being reported as severely anaemic. However, even mild and moderate anaemia, if left untreated, can lead to serious long-term health consequences.

As per the National Family Health Survey (NFHS-5, 2019–21), the prevalence of anaemia among women aged 15–49 years in Maharashtra is 57percent, and among children aged 6–59 months, it is 67.1percent. These statistics highlight the need for effective and community-based interventions. Ayurvedic medicines like Classical Ayurveda medicines like Punarnavadi mandoorDhatri lauha, Drakshavaleha, etc. are known to have their role in increasing hemoglobin and improving the symptoms associated with anaemia.

 

Aim of the study is to assess the effectiveness of Drakshavaleha on anemia among adults in selected districts of the Vidarbha region, Maharashtra

 

 
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