| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D649||Anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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
|
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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 mandoor, Dhatri 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 |