| CTRI Number |
CTRI/2026/02/104651 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [restoring balance in the body and minimizing complications] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A CLINICAL AND IN-SILICO ANALYSIS OF THE ADD-ON
EFFECT OF DRAKSHA DADIMADI AVALEHA AND GANDHAKADI YOGA TABLETS ON
THE FREQUENCY OF BLOOD TRANSFUSIONS IN THALASSEMIA MAJOR |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL AND IN SILICO ANALYSIS OF THE ADD-ON
EFFECT OF DRAKSHA DADIMADI AVALEHA AND GANDHAKADI YOGA TABLETS ON
THE FREQUENCY OF BLOOD TRANSFUSIONS IN THALASSEMIA MAJOR |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavana Nandakumar |
| Designation |
Phd Scholar, Dept of Kaumarabhritya |
| Affiliation |
All India Institute of Ayurveda |
| Address |
44 Suraj Apartments,Pul Pehladpur
New Delhi
DELHI
110044
India |
| Phone |
09315039628 |
| Fax |
|
| Email |
bhavana.nk96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajagopala S |
| Designation |
Additional professor, Dept of kaumarabhritya |
| Affiliation |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda
Sarita vihar, new delhi-110076
New Delhi
DELHI
110076
India |
| Phone |
7600902564 |
| Fax |
|
| Email |
srajagopala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhavana Nandakumar |
| Designation |
Phd Scholar, Dept of Kaumarabhritya |
| Affiliation |
All India Institute of Ayurveda |
| Address |
44 Suraj Apartments,Pul Pehladpur
New Delhi
DELHI
110044
India |
| Phone |
09315039628 |
| Fax |
|
| Email |
bhavana.nk96@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda,Sarita vihar,New delhi-110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda
Sarita vihar, New delhi-110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Bhavana Nandakumar |
All India Institute of Ayurveda |
OPD No - 208, second floor
Department of Kaumarabhritya
Sarita Vihar, Mathura road
New delhi-110076
South
DELHI |
09315039628
bhavana.nk96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D561||Beta thalassemia. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Blood transfusion | (Procedure Reference: , Procedure details: Blood transfusions once in every 2-3 week.)
| | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Draksha dadimadi avaleha, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: -(2) Medicine Name: Gandhakadi yoga tablets, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: -(3) Medicine Name: Shigru churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: -(4) Medicine Name: Vidanga churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | | - | Blood tranfusions | Blood transfusions once in every 2-3 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Hb electrophoresis diagnosed cases of Thalassemia major.
Age groups of 3 to 16 years of either sex.
Patients on a regular blood transfusion regimen to maintain a pre-transfusion hemoglobin level between 9 and 10 g per dL.
Patients having history of receiving at least 8 or more blood transfusions per year.
Parents or guardian willing to give consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Cases having HIV, HBV infection, Hepatic failure, DM, TB, malarial infection, active liver disease etc.
Other haemoglobinopathies like sickle cell anemia, hereditary spherocytosis etc.
Patients having cardiac and kidney complications.
Patients undergone Splenectomy and allogeneic bone marrow transplantation.
Known allergy to any content of Draksha dadimadi Avaleha and Gandhakadi Yoga tablets. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in blood transfusion frequency (days) and amount of blood transfused (per session). |
0 day,15th day,30th day,45th day,60th day,75th day,90th day and three month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Pandu Lakshana using predefined scoring scale |
Baseline, 4 weeks, 8 weeks, 12 weeks, and follow-up at 16 weeks. |
| Improvement in hematocrit value and reduction in serum ferritin levels. |
Baseline and 12 weeks. |
| Improvement in quality of life assessed using the TranQol scale. |
Baseline and 12 weeks. |
| Quality of Life and KAP (Knowledge, Attitude, Practices) assessment among patients and caregivers. |
Single time point, at baseline. |
| Incidence, nature, severity, and causality of adverse events or adverse drug reactions. |
Throughout the entire treatment and follow-up period (0–16 weeks). |
|
|
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)
|
17/03/2026 |
| 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="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
|
This randomized controlled clinical trial aims to evaluate the add-on effect of Draksha-Dadimadi-Gandhakadi Yoga tablets in reducing the frequency of blood transfusions among patients with Thalassemia Major. Thalassemia Major is a chronic hemoglobinopathy requiring lifelong regular transfusions, which lead to iron overload, repeated hospitalization, and reduced quality of life.
The study will enroll participants diagnosed with transfusion-dependent Thalassemia Major who meet predefined inclusion criteria. Participants will be randomly allocated into two groups: one receiving standard conventional management alone (control group) and the other receiving standard management along with Draksha-Dadimadi-Gandhakadi Yoga tablets as an add-on intervention (intervention group).
The primary outcome is the change in the frequency of blood transfusions during the study period. Secondary outcomes include changes in hemoglobin levels, serum ferritin levels, quality-of-life scores, and safety parameters. The intervention duration and follow-up are designed to assess both efficacy and safety.
This study will provide evidence on whether the Ayurvedic formulation can serve as a safe and effective adjunct therapy to reduce transfusion requirements and improve clinical outcomes in Thalassemia Major. |