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CTRI Number  CTRI/2022/06/043565 [Registered on: 29/06/2022] Trial Registered Prospectively
Last Modified On: 06/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [BASTI]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of therapeutic Enema(Yashtyahwa Niruha Basti) and Medicated Decocation (Peepal Kwath) in Gout(Vatarakta) 
Scientific Title of Study   A Comparative study to evaluate the efficacy of Yashtyahwa Niruha Basti and Bodhi Vriksha Kashaya in Vatarakta w.s.r. to Gout 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Soumya Mishra 
Designation  M.D. Scholar(Panchakarma) 
Affiliation  .Government P.G. Ayurveda College and Hospital,Varanasi.,U.P. 
Address  Department Of Panchakarma,Government P.G. Ayurveda College and Hospital,Varanasi.

Varanasi
UTTAR PRADESH
221002
India 
Phone  7275700498  
Fax    
Email  dr.soumya8884@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Padma Lochan Sankhua 
Designation  Reader and HOD,Department Of Panchakarma 
Affiliation  Government P.G. Ayurveda College and Hospital,Varanasi,U.P. 
Address  Department Of Panchakarma,Government P.G. Ayurveda College and Hospital,Varanasi,U.P.

Varanasi
UTTAR PRADESH
221002
India 
Phone  7376468851  
Fax    
Email  pls_bls@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Soumya Mishra 
Designation  M.D. Scholar(Panchakarma) 
Affiliation  Government P.G. Ayurveda College and Hospital,Varanasi,U.P. 
Address  Department of Panchakarma Government P.G. Ayurveda College and Hospital, Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  7275700498  
Fax    
Email  dr.soumya8884@gmail.com  
 
Source of Monetary or Material Support  
Government P.G.Ayurveda College and Hospital,Varanasi, U.P. 
 
Primary Sponsor  
Name  Government PG Ayurveda College and HospitalVaranasiUP 
Address  Department of panchakarma Government P.G. Ayurveda College and Hospital,Varanasi,U.P 
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 
Soumya Mishra  Government P.G. Ayurveda College and Hospital,Varanasi,U.P  Department of Panchakarma Government P.G. Ayurveda College and Hospital,Varanasi,U.P
Varanasi
UTTAR PRADESH 		 7275700498

dr.soumya8884@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Post Graduate Ayurvedic College and Hospital Sampurnanand Sanskrit University Varanasi U.P.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: VATARAKTAM, (2) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Bodhi vriksha kashaya, Reference: Ch.chi 29/158, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 16 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charak siddhi -3/46, Procedure details: Purvakarma-For Anuvasana Basti, Patients having laghu ahar are to undergo with mridu abhyanga and swedana on the area of Udara,Sphik & Pristha.The same procedure is also to be applied to the patients before Niruha Basti but it should be in empty stomach. Pradhanakarma-Til taila anuvasana basti 60ml and Yashtyahwa niruha basti 500ml(kala krama method) for 16 days. Paschatkarma-Patient is to be advised to lie in the supine position & to defecate on developing urge.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1-The patient of vatarakta having serum uric acid more than 7mg/dl in male and more than 6 mg/dl in females.
2-All 3 essential symptoms with or without non essential symptomatology
essential symptoms: sandhishu ruk sandhishu shyvathu sparsh ashahtvam
Non essential symptomatology :angagrah sandhisu kandu sandhisu daha shyavaraktatva-twakbahotamra 
 
ExclusionCriteria 
Details  1-Patients having serum uric acid more than 11.6mg/dl in males and more than 10.3 mg/dl in females.
2-The patients suffering from uncontrolled diabetes, uncontrolled thyroid disorder and other systemic disorders.
3-Pregnancy and lactating female patients.
4-The patients having symptoms of vatrakta upadrava;hikka,murcha,moha,visarpa,manskoth,angulivakrata
5-Chronic joint deformity, marked dysfunction, discharging tophi.
6-Known cases of SLE, renal disease, hepatic disease, patients on ATT , cardiac patients on low dose aspirin, RA, OA, Psoriatic arthritis.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief from essential symptoms like pain, swelling and tenderness  16 days 
 
Secondary Outcome  
Outcome  TimePoints 
Decreased serum uric acid level.  16 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 2/ Phase 3 
Date of First Enrollment (India)   01/07/2022 
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
Modification(s)  		 Worid Journal of Pharmaceutical Research Title:Role of Yashtyahwa Niruha Basti in the management of Vatarakta w.s.r. to Gout : A Case Study D.O.I.10.20959/wjpr 202310-28628 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   clinical study:
 patients of vatarakta will be selected from the OPD and IPD of the Government P.G. Ayurveda college and hospital, Varanasi.
1.Inclusion criteria : patients with serum uric acid more than 7mg/dl in males and more than 6 mg/dl in females.
2.Exclusion criteria:  patients with serum uric acid more than 11.6mg/dl in males and 10.3 mg/dl in females.
3. groups: 
Group A : 30 patients will be given tila taila anuvasana basti and yashtyahwa niruha basti alternately for 16 days( kala krama method).
Group B: 30 patients will be given bodhi vriksha kashaya 50ml orally with madhu anupana in empty stomach twice a day for 16 days.
4. assessment criteria: the study will be carried out for 30 days. the patient will be assessed on day 1 day 16th and day 30th on the basis of symptoms and uric acid level.
5. statistical analysis method: the parameters of baseline will be compared with the follow-up status for the assessment of results.
 
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