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CTRI Number  CTRI/2021/11/038245 [Registered on: 25/11/2021] Trial Registered Prospectively
Last Modified On: 24/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "Yakritapleeha Vikar (Hepatomegaly & Splenomegaly) me Manadya Gutika aur Shobhanjanadi Kwath ka Chikitsatmak Adhyayan"  
Scientific Title of Study   “A Clinical and Comparative Study of Manadya Gudika & Shobhanjanadi Kwath in the management of Yakritpleeha Vikar.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Janmajay Sidar 
Designation  PG Scholar Department Of Kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur(C.G.) 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur(C.G.)

Raipur
CHHATTISGARH
492010
India 
Phone  8817204528  
Fax    
Email  janma.593@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pramod Kumar Baghel 
Designation  Lecturer Department Of Kayachikitsa Government Ayurved College Raipur (C.G.) 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur(C.G.) 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur(C.G.)

Raipur
CHHATTISGARH
492010
India 
Phone  8965902989  
Fax    
Email  drpkbaghel08@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pramod Kumar Baghel 
Designation  Lecturer Department Of Kayachikitsa Government Ayurved College Raipur (C.G.) 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur(C.G.) 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur(C.G.)

Raipur
CHHATTISGARH
492010
India 
Phone  8965902989  
Fax    
Email  drpkbaghel08@gmail.com  
 
Source of Monetary or Material Support  
Department Of Kayachikitsa Government Ayurved College Raipur (C.G.) 
 
Primary Sponsor  
Name  Department of Kayachikitsa Govt Ayurved College Raipur CG 
Address  Shri Narayan Prasad Awasthi Govt. Ayurved College Raipur (C.G.) 
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 
Dr Janmajay Sidar  Shri Khudadad Doongaji Government Ayurved Hospital Raipur (C.G.)  OPD Room No. 1 and 18 IPD Male Ward and Female ward, Department of Kayachikitsa, Shri Khudadad Doongaji Government Ayurved Hospital Raipur (C.G.)
Raipur
CHHATTISGARH 		 8817204528

janma.593@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OFFICE THE PRINCIPAL, Government Ayurved College Raipur (C.G.) Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E70-E88||Metabolic disorders. Ayurveda Condition: YAKRITAPLEEHA VIKAR,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Manadya Gutika , Reference: Pleehyakrita Chikitsa ,chapter 38, shloka no. 15-17/chapter 38, Page no- 378 Chakradatta chikitsa sangrah of chakrapanidatta English translation by Dr. Prabhakara Rao, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: - Ushandak ( Lukewarm Water )), Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: shobhanjanadi kwath, Reference: chakra dutta ( Prabhakar Rao )pleehyakrit chikitsa , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: manadyagutika), Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients in the age group of 18 to 60 years will be taken.
2. The patients of "Yakritapleeha Vikar" will be selected on the basis of clinical preferences described in Ayurveda:-

Anemia (Raktalpta)
Loss of appetite ( Khudhanash)
fever ( Mridu Jwar)
anorexia (Aruchi)
Vomiting (Vaman)
Enlarge liver and spleen ( Yakrita and Pleeha vridhi)

Reference - Charak chikitsa 13/ 37-38
 
 
ExclusionCriteria 
Details  • Liver abscess ( Pyogenic and Amoebic )
• Cirrhosis of liver
• liver failure
• Ischemic heart disease
• Chronic renal failure
• Nephrotic syndrome
• Sickle cell anaemia
• Severe HTN [ B.P. more than 150/100 ]
• Hepatocellular or any other carcinoma
• Portal hypertension
• Tuberculosis
• Ascites
• HIV - Positive
• Type 1 DM
• Cancer
• Sexual Transmitted Disease.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Manadya Gudika
Reference:- Chakradatta yakritapleeha rogadhikar chapter 38/17
(English translation by Dr. Prabhakar Rao )

Total no. of Content drugs:- 15 drugs
1. Mankanda
2. Apamarg
3. Guduchi
4. Vasa
5. Shalparni
6. Pipali
7. Chitrak
8. Shunthi
9. Talpushapa
10. Saindhav
11. Vid Lavan
12. Sauvarchal Lavan
13. Yava Kshar
14. Gomutra
15. Madhu

Drug Form :- Gutika
Dose :- 500mg tab / Morning and evening time after meal
Anupan :- Ushnodaka (Lukewarm Water)
 		 90 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Shobhanjanadi Kwath
Reference:- Chakradatta yakritapleeha rogadhikar chapter 38/08 (English translation)

Total no. of Content drugs:- 04 drugs
1. Shobhanjana
2. Pipali
3. Saindhav
4. Chitrak

Drug Form :- Kwath
Dose :- 20 ml / Morning and evening time empty stomach
 		 90 Days  
 
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 1 
Date of First Enrollment (India)   04/12/2021 
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   Nil 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  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 - Data are available indefinitely at (Link to be included janma.593@gmail.com).

  6. For how long will this data be available start date provided 03-10-2021 and end date provided 21-06-2022?
    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  
 
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