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CTRI Number  CTRI/2025/04/083859 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Aahar Kalpana (Panak)]  
Study Design  Single Arm Study 
Public Title of Study   Management of Iron Deficency Anemia using Drakshapanak 
Scientific Title of Study   A pilot study to evaluate the effect of Drakshapanak at Serum Hemoglobin level in 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  Vaidya Shivani Sanjay Saxena 
Designation  Msc Scholar 
Affiliation  National Institute of Ayurveda Jaipur 
Address  Department of Ayurveda Diet and Nutrition National Institute of Ayurveda, De Novo Near Jorawar Singh Gate, Amer Road

Jaipur
RAJASTHAN
302002
India 
Phone  7240070933  
Fax    
Email  shivanissaxena07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Durgawati Devi  
Designation  Professor and HOD 
Affiliation  National Institute of Ayurveda Jaipur  
Address  Department of Ayurveda Diet and Nutrition National Institute of Ayurveda, Deemed University Near Jorawar Singh Gate, Amer Road

Jaipur
RAJASTHAN
302002
India 
Phone  7073746600  
Fax    
Email  dvd6197@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kamla R Nagar  
Designation  Associate Professor  
Affiliation  National Institute of Ayurveda Jaipur  
Address  Department of Ayurveda Diet and Nutrition National Institute of Ayurveda, Deemed University Near Jorawar Singh Gate, Amer Road

Jaipur
RAJASTHAN
302002
India 
Phone  9414455797  
Fax    
Email  kamlarnagar@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Deemed University, Jaipur, India, 302002 
 
Primary Sponsor  
Name  National Institute Of Ayurveda, Deemed University, Jaipur 
Address  National Institute Of Ayurveda, Deemed University Near Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan - 302002 
Type of Sponsor  Government medical college 
 
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 Shivani Saxena  National Institute Of Ayurveda, Jaipur   Department of Ayurveda Diet and Nutrition National Institute of Ayurveda, Deemed University Near Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN 		 7240070933

shivanissaxena07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute of Ayurveda Jaipur   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 ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Drakshapanak (Panak Kalpana of Kritanna Varga) Dose: 100 ml Frequency: Once daily Route Of Administration: Orally Total duration of Intervention:2 months, Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Age group 18 - 45 years of either sex that are previously diagnosed with Iron Deficiency Anemia  
 
ExclusionCriteria 
Details  Severe anemic patients
Lactating and Pregnant women
Women planning pregnancy
Using vitamin and mineral supplements
Frequent blood donors
Have had major surgeries in the past 3 months
Plan of surgery in course of study
Alcohol consumption
Known cases of; Ulcerative colitis, chronic kidney disease, diverticular bleeding, irritable bowel syndrome, helicobacter pylori, hookworm infestation, blood clotting disorders.
Using NSAIDs, antacid, corticosteroids, antiviral drugs.


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in Serum Hemoglobin level before and after the completion of study  2 Months 
 
Secondary Outcome  
Outcome  TimePoints 
N.A  N.A 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   10/04/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

NEED OF THE STUDY

The objective of the pilot study is to evaluate the effect of Drakshapanak, an Ayurvedic Ahara kalpana from the classical literature in the management of Iron deficiency anemia.

 

PREVIOUS RESEARCH WORK:

 No such previous study available.

 

RATIONAL FOR SELECTION OF INTERVENTIONS/ JUSTIFICATION FOR SELECTION OF TRIAL DRUGS

 

Iron deficiency anemia is one of the foremost common causes of anemia. The use of Ayurveda Aahar Kalpana can be a good solution towards the management of same since these are easily accessible besides being easy to prepare, administer, cost effective and a natural substitute to synthetic iron supplements. It may also help in avoidance of possible side effects of use of supplements.

RESEARCH QUESTION

Is Drakshapanak is effective in accession of Serum Hemoglobin levels in Iron deficiency anemia?

Study Design

Study Type: Interventional study (Single group pre and post study design).

Phase of study: 2nd

Number of Groups: 1 Group

Site of study: Department of Ayurveda Diet and Nutrition, National Institute of Ayurveda, Jaipur.

STUDY SETTING: National Institute of Ayurveda, Jaipur Hospital (outdoor/indoor).

STUDY DURATION: 2 months


Details of Trail drug:

Sr No.

Name of Ingredient

Latin Name

Part used

Quantity (Ratio)

1.

Draksha

Vitis vinifera

Fruit

1

2.

Parushak

Grewia asiatica

Fruit

1

3.

Kharjoor sar

Phoenix dactylifera

Fruit

1

4.

Kola(Badar bhed)

Ziziphus Jujuba

Fruit

1

5.

Jala

Water

N. A

1

6.

Guda(Jaggery)

Saccharum officinarum

N. A

1

7.

Ikshu Rasa (Sugarcane juice)

Saccharum officinarum

N. A

1

8.

Chaturjaat

Cinnamomum zeylanicum, Elettaria cardamomum, Cinnamomum tamala,

Mesua ferrea

Fruit, Leaf

Q. S

9.

Karpur

Cinnamomum camphora

Extract

Q. S

10.

Maricha

Piper nigrum

Fruit

Q. S

Dose form: Liquid  

Time of administration: After meal

Route of administration: Orally

Anupana: None

Duration:

·       Time Frame: 8 weeks or 2 months (Including follow-up period)

·       Trial Period: The duration of study will be for 8 weeks.

·       Follow Up:

Ø  First follow up on 2nd week or on 15th day.

Ø  Second follow up on 4th week or on 30th day.

Ø  Third follow up on 6th week or on 45th day.

Ø  Fourth follow up on 8th week or on 60th day. 

INVESTIGATIONS:

Name of Investigation

Purpose

Timings for Investigations

Serum Hemoglobin

To diagnose mild to moderate anemia.

Before and after completion of study.

 ASSESSMENT CRITERIA: The result of clinical study will be assessed on the basis of changes in Serum Hemoglobin levels before and after the completion of study.



 
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