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CTRI Number  CTRI/2025/05/087787 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 24/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Ayurvedic formulation in Pandu Roga (Anemia). 
Scientific Title of Study   A Comparative clinical study of Draksha Ghrita with Ferrous Ascorbate in Pandu Roga w.s.r.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  Richa Thakur 
Designation  PG Scholar 
Affiliation  Abhilashi Ayurvedic College and Research Institute Chailchowk Mandi.H.P. 
Address  Department of Kayachikitisa Abhilashi Ayurvedic College and Research Institute Chailchowk Tehsil- Chachyot Mandi. Himachal Pradesh

Mandi
HIMACHAL PRADESH
175045
India 
Phone  9459359206  
Fax    
Email  richa17thakur@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Richa Thakur 
Designation  PG Scholar 
Affiliation  Abhilashi Ayurvedic College and Research Institute Chailchowk Mandi.H.P. 
Address  Department of Kayachikitisa Abhilashi Ayurvedic College and Research Institute Chailchowk Tehsil- Chachyot Mandi. Himachal Pradesh

Mandi
HIMACHAL PRADESH
175045
India 
Phone  9459359206  
Fax    
Email  richa17thakur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pankaj Sharma 
Designation  Associate Professor 
Affiliation  Abhilashi Ayurvedic College and Research Institute Chailchowk Mandi.H.P. 
Address  Department of Kayachikitisa Abhilashi Ayurvedic College and Research Institute Chailchowk Tehsil- Chachyot Mandi. Himachal Pradesh

Mandi
HIMACHAL PRADESH
175045
India 
Phone  9882339703  
Fax    
Email  Dr.pankaj8600@gmail.com  
 
Source of Monetary or Material Support  
Abhilashi Ayurvedic College and Research Institute chailchowk Tehsil- Chachyot Distt. Mandi. Himachal Pradesh Pin code -175028 India. 
 
Primary Sponsor  
Name  Abhilashi Ayurvedic College and Research Institute  
Address  Abhilashi Ayurvedic College and Research Institute chailchowk Tehsil- Chachyot Distt. Mandi. Himachal Pradesh PIN CODE - 175028. India 
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 
DrRicha Thakur  Abhilashi Ayurvedic college and Research Institute Chailchowk Mandi H.P.  Department of Kayachikitsa Room no.-305, 3rd floor Abhilashi Ayurvedic college and Research Institute Chailchowk Tehsil- Chachyot Distt Mandi H.P 175028. India
Mandi
HIMACHAL PRADESH 
9459359206

richa17thakur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Abhilashi Ayurvedic College and Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Draksha Ghrita, Reference: Charak chikitsa sthana 16/52, Route: Oral, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Ushnodaka), Additional Information: -
2Comparator Arm (Non Ayurveda)-Ferrous AscorbateFerrous Ascorbate Dose- 100mg OD Route of Administration- Oral Duration- 60days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patient having Hb in between 7-11 gm percent
Patient willing to participate in the trial. 
 
ExclusionCriteria 
Details  Patient having age group less than 18yrs or more than 45 yrs
Patient having Hb level less than 7gm percent and greater than 11gm percent
Patient suffering from major systemic illness Tuberculosis,Rheumatoid arthritis, Gastric ulcers, bleeding disorders( Menstrual disorders) , CKD, Hypertension,Diabetes mellitus, Malignancies.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of effect of two therapies will be done on the basis of prepared performa and improvement in parameters . Subjective Criteria:
Panduta - Twacha, nakha, netra, jihwa, hastapada
Daurbalyata
Hridyaspandanam
Ayasaja swasa
Bhrama
Pindikodwestana
Objective Criteria-
CBC with ESR
PBF( Peripheral blood film)
RFT( Renal function test)
LFT( Liver function test)
S.Ferrintin  
60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in criteria listed in different scales.
Marked Improvement - 75% Relief in clinical features and rise in Hb 3gm%
Moderate Improvement -50-75% relief in clinical features and rise in Hb 2gm%
Mild Improvement- 25-50% relief in clinical features and rise in Hb 1gm%
No Improvement - 25% relief in signs and symptoms and rise in Hb less than 1gm%  
60 days 
 
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 
Date of First Enrollment (India)   10/06/2025 
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="1"
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  
  A COMPARATIVE CLINICAL STUDY OF DRAKSHA GHRITA WITH FERROUS ASCORBATE IN PANDU ROGA W S R  TO IRON DEFICIENCY ANEMIA  

 

Public title of the study 

Effect of Ayurvedic formulation in Pandu Roga  Anemia  

 

Scientific Title of the study 

A comparative Clinical Study of Draksha Ghrita with Ferrous Ascorbate in Pandu Roga W S R to Iron Deficiency Anemia 

 

Principal Investigator’s Name 

Dr  Richa Thakur  

                    P G Scholar 

 

Institute 

Abhilashi Ayurvedic Medical College and Research Institute  Chail  Chowk  

Mandi H P 



Guide 

Dr  Yogesh Sharma  

                    M D    Ayu   Professor 

 
Co  Guide  

Dr  Pankaj Sharma 

                    M D  Ayu   Associate Professor 

 

Place of Study 

Abhilashi Ayurvedic Medical College and Research   Institute  Chail Chowk 

 Mandi H P 

 

Introduction 

Rapid lifestyle changes are increasing nutritional disorders  

Iron Deficiency Anemia  IDA  is a major global and Indian health issue  

WHO  One third of global population is anemic  

IDA causes fatigue  heart issues  low immunity  etc  

Ayurveda identifies IDA as Pandu Roga  linked with Pitta dosha imbalance  


Side effects with Modern Medicine 

Common treatments use iron salts  Ferrous sulfate  ascorbate  etc    

Side effects include nausea  constipation  metallic taste  etc  

Need for safe  effective  natural alternatives  


Ayurvedic Perspective 

Pandu Roga described in Charak Samhita  

Draksha Ghrita  A classical Ayurvedic formulation  

Ghee based herbal compound  

Benefits  Pacifies Pitta  strengthens digestion  promotes healthy blood  Rakta Dhatu   


Aim and Objectives 

Aim  Evaluate the efficacy of Draksha Ghrita in managing Pandu Roga  IDA   

Objectives  

1  Compare Draksha Ghrita with Ferrous Ascorbate  

2  Assess safety of Draksha Ghrita  


Methodology 

Design  Randomized clinical trial  

Subjects  30 patients with IDA  Hb 7 to 11 gm percent  aged 18 to 45 years   

Groups  

  Group 1  Draksha Ghrita  5g twice day   

  Group 2  Ferrous Ascorbate  100 mg once day   

Duration  60 days 

Follow up  Day 20  40  60 


Inclusion Exclusion Criteria 

Inclusion  

  Age 18 to 45 years

  Hb  7 to 11 gm percent 

  Willingness to participate 


Exclusion  

 Major systemic illness    Tuberculosis  R A  Gastric Ulcers  Bleeding Disorders  Menstrual Disorders   CKD   Hypertension   Diabetes Mellitus   Malignancies  

  Hb greater than 7 or Less than 11 gm percent 

  Age greater than 18 or Less than 45 


Assessment Criteria 

Subjective  

Panduta  Daurbalyata  Hridyaspandanam  Ayasaja Swasa  Bhrama  Pindikodwestana  Pallor  Weakness  Palpitations  Breathlessness  Dizziness  Calf pain  

Objective  

CBC  ESR  Peripheral smear  Serum Ferritin  RFT  LFT 


Outcome Grades  

 Marked  Less than 75percent relief and Hb more than or equals  3 gm percent 

 Moderate  50to 75percent and Hb more than or equals 2 gm percent 

Mild  25 to 50percent and Hb more than equals 1 gm percent 

No Improvement  greater than 25percent and Hb  greater than 1 gm percent 


Trial Drug  Draksha Ghrita 

Composition  

  Go ghrita  Ghee   1 part 

  Draksha  Vitis vinifera   One half part  paste form  


Benefits  

  Treats anemia  jaundice  digestive issues 

  Pacifies Pitta and Vata 

  Improves blood and nutrition assimilation 

 
 
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