FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070971 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 19/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The Impact of Nisha Loha and Ayorajaji Churna on Pandu (Iron Deficiency Anaemia) 
Scientific Title of Study   A Comparative Clinical Study Of Ayorajadi Churna And Nisha Loha In Pandu (Iron Deficiency Anaemia)  
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 Rahul Suthar  
Designation  MD Scholar 
Affiliation  PG Department Of Kriya Sharir , Dr. S.R. Rajasthan Ayurved University, Jodpur, Rajasthan, India 
Address  PG Department Of Kriya Sharir Post Graduate Institute of Ayurveda, Jodhpur DSRRAU, Jodhpur, Rajasthan, India 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  8233276077  
Fax    
Email  dr.rahulsuthar07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh Chandra Sharma 
Designation  Associate Professor 
Affiliation  Post Graduate Institute of Ayurveda, Jodhpur  
Address  Room No-141 PG Department of Kriya Sharir Post Graduate Institute of Ayurveda, Jodhpur DSRRAU, Jodhpur Kadwad, Rajasthan, India, 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  9461691454  
Fax    
Email  dr_dcsharma@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Suthar  
Designation  MD Scholar 
Affiliation  Post Graduate Institute of Ayurveda , Jodhpur ,Rajasthan 
Address  PG Department of Kriya Sharir Post Graduate Institute of Ayurveda , Jodhpur DSRRAU, Jodhpur, Rajasthan, India 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  8233276077  
Fax    
Email  dr.rahulsuthar07@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Ayurved DSRRAU Jodhpur, Nagaur Road, Kadwad, Jodhpur, Rajasthan Jodhpur Rajasthan India 342037 
 
Primary Sponsor  
Name  Post Graduate Institute Of Ayurved Jodhpur 
Address  PG Department Of Kriya Sharir DSRRAU, JODHPUR Nagaur Road Kadwad, Jodhpur, RAJASTHAN INDIA 342037 
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 Rahul Suthar  Post Graduate Instituate of Ayurveda ,Jodhpur  Room no. 141, PG Department Of Kriya Sharir Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur Road Kadwad, Jodhpur, Rajasthan, India 342037
Jodhpur
RAJASTHAN 		 8233276077

dr.rahulsuthar07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Post Graduate Institute Of Ayurved Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E611||Iron deficiency. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ayorajadi churna, Reference: Shushruta Samhita Uttar Tantra 44/19, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu-Sarpi), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Nisha Loha , Reference: Bhaishajya Ratnavali 12/29, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu- Sarpi), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Pandu Roga diagnosed according to subjective and objective parameters
Age group between above 18 years and below 60 years of either sex having cardinal symptoms of Pandu.
Blood sample showing Hb percentage in range [in men 7–13 g/dl and in females 7–12 g/dl]
Patients willing to participate in clinical trials.

 
 
ExclusionCriteria 
Details  Patients suffering from systemic diseases like renal disorders, heart disease, cancer, or tuberculosis.
Patients with an age below 18 years and above 60 years.
Patients with Hb% less than 7 g/dl.
Pregnant &lactating women’s.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the differences in changes in iron deficiency anemia between Ayorajadi churna and Nisha loha.
 		 45 days 
 
Secondary Outcome  
Outcome  TimePoints 
changes in the clinical sign & symptoms of Pandu.  45days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 4 
Date of First Enrollment (India)   10/08/2024 
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="1"
Days="15" 
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   Number of Patients: 60 (each group have 30 patients)

Type of Study: open-label

Drugs: -Group A:  Ayorajadi Churna
 
            Group B, Nisha loha 

Dose: Group A: Ayorajadi Churna, 1 gram orally twice a day after meal
 
Anupan-  Madhu, and Sarpi

Route: Oral Route 

Group B:  Nisha loha 250 mg orally twice a day after meal

Anupan-   Madhu, and Sarpi

Route:      Oral Route 

Duration of Study:  45 days 

Follow-up: Each 15th Days during study and after 15th  Days of completion of study
Purpose of the Trial: To evaluate the effect of Ayorajadi Churna on Pandu in comparison with Nisha loha.
 
Close