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CTRI Number  CTRI/2024/07/071154 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Efficacy of Yakridari loha in the management of Anemia in Udara( liver cirrhosis). 
Scientific Title of Study   Prospective single arm open clinical trial to study the efficacy of Yakridari Loha in the manangement of Pandu in Udara with special reference to Anemia in Liver Cirrhosis. 
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 Farheenben Vohra 
Designation  PG Scholar 
Affiliation  Seth Chandalmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara 
Address  PG Depatment of Kayachikitsa, M N Agashe Aryangla Hospital , Shukravar Peth , Satara.
S.C.Mutha Aryangla Vaidyak Mahavidyalaya, Satara, Gendamal, ITI Road, Satara 415002
Satara
MAHARASHTRA
415002
India 
Phone  7738904684  
Fax    
Email  farheenv94@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P D Londhe 
Designation  Professor and HOD  
Affiliation  Seth Chandalmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara 
Address  Cabin No. 1,PG Department of Kayachikitsa Seth Chandalmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara
S.C.Mutha Aryangla Vaidyak Mahavidyalaya, Satara, Gendamal, ITI Road, Satara 415002
Satara
MAHARASHTRA
415002
India 
Phone  9422435765  
Fax    
Email  drpdlondhe4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Farheenben Vohra 
Designation  PG Scholar 
Affiliation  Seth Chandalmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara 
Address  PG Department of Kayachikitsa, M N Agashe Aryangla Hospital , Shukravar Peth , Satara.
S.C.Mutha Aryangla Vaidyak Mahavidyalaya, Satara, Gendamal, ITI Road, Satara 415002
Satara
MAHARASHTRA
415002
India 
Phone  7738904684  
Fax    
Email  farheenv94@gmail.com  
 
Source of Monetary or Material Support  
Seth Chandalmal Mutha Aryangla Vaidyak Mahavidyalaya,Gendamal,ITI Road, Satara, Maharashtra, India 415002 
 
Primary Sponsor  
Name  Dr Farheenben Vohra 
Address  S.C.Mutha Aryangla Vaidyak Mahavidyalaya, Satara, Gendamal, ITI Road, Satara 415002 
Type of Sponsor  Other [Self] 
 
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 P D Londhe  Seth Chandalmal Mutha Aryangla Vaidyak Mahavidyalaya Satara  Room no.4 OPD BlockDepartment of Kayachikitsa, MN Agashe Aryangla Hospital, Satara.
Satara
MAHARASHTRA 		 9422435765

drpdlondhe4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, SCM Aryangla Vaidyak Mahavidyalaya, Satara.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D539||Nutritional anemia, unspecified. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Yakridari Loha, Reference: Bhaishajya Ratnavali Pleehayakrutrogachikitsa 131, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients having cardinal signs and symptoms of Pandu in Udara as per ayurvedic texts without any bar of caste, sex and religion.
2.Patients having Haemoglobin level between 5 to 12gm%. 
 
ExclusionCriteria 
Details  1.Chidrodar
2.Acute MI
3.Malignancy
4.Pregnancy
5.Hepatic Encephalopathy
6.SLE
7.Recent MI
8.Patient in condition of precoma and coma(Overt & Covert Coma)
9.HIV & HBsAg positive patients
10.Complicated Liver Disorders with ascites
11.Congenital & hereditary disorders.
12.Metabolic Disorders like Myxedema, Thyroid etc 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the hematinic effect of Yakridari Loha in Pandu in Udara  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate the hematinic effect of Yakridari Loha in Pandu in Udara

 		 7th day, 14th day & 21st day 
2.To study the adverse effects of Yakridari Loha, If any.  7th, 14th & 21st day. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   07/08/2024 
Date of Study Completion (India) 30/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/09/2024 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Research article sent for publication 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [farheenv94@gmail.com].

  6. For how long will this data be available start date provided 07-07-2024 and end date provided 07-07-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Current Clinical Trial is Titled as " Prospective single arm open clinical trial to study the efficacy of Yakridari loha in the management of pandu in udara with special reference to Anemia in Liver cirrhosis".

The trial drug used in this clinical study is Yakridari loha which will be given in the dose 500mg twice a day for 21 days.

The sample size of this study will be 30.

It is single arm prospective open clinical trial.

The patient will be  selected from opd and Ipd of our concerned institute.

the purpose of the trial is to assess the efficacy of Yakridari loha.

The Null Hypothesis for this trial is -Yakridari Loha 500mg orally twice a day for 21 days is not effective in the management of Pandu in Udara with special reference to Anemia in liver Cirrhosis.

The Alternate Hypothesis for this trial is -Yakridari Loha 500mg orally twice a day for 21 days is  effective in the management of Pandu in Udara with special reference to Anemia in liver Cirrhosis.

Observation and Results - 

Above clinical research study in 30 patients of Pandu in Udara w.s.r. to  Anemia in Liver Cirrhosis with Yakridari Loha shows following results 

In subjective criteria it is evident that total no of patients shows 

59.68% relief in Panduta parameter, 52.28% relief in Hridspandana, 57.69% relief in Shwaskashtata, 71.67% relief in Daurbalyata, 68.75% relief in Aruchi, 68% relief in Agnimandya, 75.68% relief in Pindikodwestana and 30.30% relief was seen in Pada shotha.

Overall 60.52% relief is observed in subjective criteria.

In objective criteria, for Hb%, statistically high significant difference was seen in values between the time intervals. For total bilirubin and SGPT also, statistically significant difference was seen in values between the time intervals. Hence, Hb%, T.B. and SGPT showed statistically significant result. Whereas, in TLC, ESR, SGOT, Blood urea, Serum creatinine, Urine RBCs and Urine Albumin parameters, there was statistically no significant difference seen in values between the time interval. Therefore, these parameters showed statistically not significant result.

Tab Yakridari Loha showed marked improvement (i.e.76%-100%) in 12(40%) patients of Pandu in Udara with special reference to anemia in liver cirrhosis. It showed Moderate improvement (i.e. 51%-75%) in 12 (40%) patients and gave mild improvement (i.e. 26%-50%) in 2(6.67%) patients. 3 (10%) patients showed no improvemet (i.e. 0%-25%) to Tab Yakridari Loha.

Conclusion - 

Based on P value, it can be concluded that the Null Hypothesis is rejected and the Alternative Hypothesis can be retained, indicating that Yakridari Loha is effective in the management of Pandu In Udara w.s.r. to Anemia in Liver Cirrhosis. 

There is no noticeable adverse effects of the drug observed during the treatment period. Yakridari Loha is clinically safe and effective preparation that does not have any side effects in managing Pandu in udara when combined with proper Pathya and Aahar-Vihar. 

 
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