| CTRI Number |
CTRI/2025/10/096536 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
25/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to assess the effect of an Ayurvedic iron-based formulation in people suffering from iron deficiency anemia |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Evaluate the Efficacy of Gomutra Bhavita Lohbhasma with Milk in the Management of Pandu with Special Reference to Iron Deficiency Anemia |
| 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 Haritha T N |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no. 201, Department of Swasthavritta and Yoga, National Institute of Ayurveda, Deemed University, Jorawar Singh Gate, Amer Road, Jaipur, 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9539585142 |
| Fax |
|
| Email |
thamattoorh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Kumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no. 204, Department of Swasthavritta and Yoga, National Institute of Ayurveda, Deemed University, Jorawar Singh Gate, Amer Road, Jaipur, 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9555554077 |
| Fax |
|
| Email |
drravikumar786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Haritha T N |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no. 201, Department of Swasthavritta and Yoga, National Institute of Ayurveda, Deemed University, Jorawar Singh Gate, Amer Road, Jaipur, 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9539585142 |
| Fax |
|
| Email |
thamattoorh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Funded under Institutional Research Grant, National Institute of Ayurveda, Deemed University, Jorawar Singh Gate, Amer Road, Jaipur, India, Pincode - 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda, Deemed University, Jorawar Singh gate, Amer Road, Jaipur, 302002 |
| Type of Sponsor |
Government medical college |
|
|
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 Haritha T N |
National Institute of Ayurveda |
OPD no. 21, Department of Swasthavritta and Yoga, National Institute of Ayurveda, Deemed University, Jorawar Singh Gate, Amer Road, Jaipur, 302002
Jaipur
RAJASTHAN |
9539585142
thamattoorh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gomutra bhavita Lohabhasma, Reference: Charaka Samhita, Chikitsa Sthana, Panduroga Chikitsa, Route: Oral, Dosage Form: Bhasma, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard Iron Supplement | Standard Iron Supplement, BID, 8weeks, after food, with water | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gomutra bhavita Lohabhasma, Reference: Charaka Samhita, Chikitsa Sthana, Panduroga Chikitsa, Route: Oral, Dosage Form: Bhasma, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Milk), Additional Information: Gomutrabhavita Lohabhasma |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with iron-deficiency anemia |
|
| ExclusionCriteria |
| Details |
Severe anemia. Patients with Lactose intolerance. Patients with Lactose intolerance. Patients with systemic diseases, bleeding disorders or on other iron
supplements. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in hemoglobin levels from baseline to week 8 |
baseline and week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in haematological parameters such as Heamoglobin, Serum Iron Level,
Serum Ferritin, Total Iron Binding Capacity etc. |
baseline to week 8 |
Improvements in anemia-related symptoms, such as fatigue, weakness, and
pallor. |
baseline to week 8 |
|
|
Target Sample Size
|
Total Sample Size="141"
Sample Size from India="141"
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)
|
01/12/2025 |
| 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="12"
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
|
Anemia, particularly iron deficiency anemia, is a major global health concern, affecting a large proportion of the population, especially women and children in developing countries like India. The present study is a randomized controlled trial designed to evaluate the efficacy of Gomutra Bhavita Lohabhasma with milk in the management of Pandu with special reference to iron deficiency anemia. Lohabhasma, an Ayurvedic formulation, is traditionally used to replenish iron stores and enhance hematopoiesis. The Bhavana process with Gomutra is believed to potentiate its efficacy and detoxify the metal component, while milk as an adjuvant supports nourishment and reduces gastrointestinal irritation.
The study will include 141 participants randomly divided into three groups: Group I will receive Gomutra Bhavita Lohabhasma with milk, Group II will receive the same drug with water, and Group III will receive standard iron supplementation. The treatment period will be 8 weeks with follow up every 15 days. Hemoglobin and other hematological parameters, along with clinical symptoms of anemia, will be assessed before and after treatment. This research aims to validate the traditional Ayurvedic approach using modern clinical methodology and to explore a safe, effective, and culturally acceptable alternative in the management of iron deficiency anemia. |