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CTRI Number  CTRI/2024/12/077694 [Registered on: 05/12/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to evaluate the efficacy of bodhivriksha (Ficus Religiosa) kashaya basti in the management of vatarakta w.s.r. gouty arthritis 
Scientific Title of Study   An open label randomized controlled trial to evaluate the efficacy of bodhivriksha (Ficus Religiosa) kashaya basti in the management of vatarakta w.s.r. to gouty arthritis 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nitish 
Designation  M D Panchkarma Scholar 
Affiliation  Institute for ayurved studies and research Shri krishana AYUSH university  
Address  Room no 29 1st floor Institute for ayurved studies and research Shri krishana AYUSH university kurukshetra Haryana 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  7015429162  
Fax    
Email  nk7876477@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Ashish Mehta 
Designation  Chairperson, PG Department of Panchkarma 
Affiliation  Institute for ayurved studies and research Shri krishana AYUSH university 
Address  Room no 67 1st floor Institute for ayurved studies and research Shri krishana AYUSH university kurukshetra Haryana 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  8950375285  
Fax    
Email  drashishhmehta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nitish  
Designation  M D Panchkarma Scholar 
Affiliation  Institute for ayurved studies and research Shri krishana AYUSH university  
Address  Room no 29 1st floor Institute for ayurved studies and research Shri krishana AYUSH university kurukshetra Haryana 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  7015429162  
Fax    
Email  nk7876477@gmail.com  
 
Source of Monetary or Material Support  
Institute for ayurved studies and research Shri krishana AYUSH university kurukshetra haryana 136118 india 
 
Primary Sponsor  
Name  Institute for ayurved studies and research Shri krishana AYUSH university 
Address  Sector 8 Umri road kurukshetra 136118 Haryana India 
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 Nitish  Institute for Ayurved and studies and Research, Shri Krishna AYUSH University   Room no. 29 first floor shri krishna AYUSH university hospital Umri road sector 8 kurukshetra
Kurukshetra
HARYANA 		 07015429162

nk7876477@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee of university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charak samhita chikitsa 29, Procedure details: Total 16 basti(yoga basti) will be given in 9 days (9 basti of murchita tila tailam in the evening & 6 bodhivriksha kashaya basti in morning empty stomach).)
(1) Medicine Name: Bodhivriksha kashaya , Reference: Charak samhita chikitsa 29, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 160(ml), Frequency: od, Duration: 6 Days
2Comparator Arm (Non Ayurveda)-AlllopurinolTablet allopurinol 300 mg hs for 10 days will be given.
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing to sign the conset form.
Patient between the age sub-group of 30-60 years of either sex.
Patients presenting with clinical features of vatarakta.
Assessment of gouty arthritis by assessment criteria.(ARA criteria and ACR and EULAR criteria)
Patient with chronicity of disease less than 2 years.
Patients fit for basti karma (basti yogya).
Serum uric acid range 6.00 mg/dl to 9.00 mg/dl. 
 
ExclusionCriteria 
Details  Subjects with chronicity of disease more than 2 years.
Subjects of either sex age below 30 years and above 60 years.
The patients unfit for Basti Karma.
Patients having systematic pathologies like cardiac disease and hypertension.
Subjects with uncontrolled diabetes, systemic disorders and endocrine disorders.
Patients having tuberculosis of spine, spinal tumors, vertebral fractures, surgical conditions, and auto immune disease like ankylosing spondylitis.
Both groups: Rectal prolapse, Fever, Pregnant and lactating mothers etc.
Known case of Rheumatoid Arthritis, Psoriatic Arthritis, Patients with renal or hepatic impairment Serum creatinine more than 1.8mg/dl along with Serum Urea more than 60 mg/dl.
Patients requiring emergency treatment 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The proportion of patients showing improvement in the level of sr. uric acid post Basti karma.  Ist- 0 Day.
IInd - After the completion of trial.
IIIrd- 10 days after Basti karma 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the symptoms of patient like sandhi shotha (swelling), sandhi shool (pain),
stadabhta (stiffness) etc. as described in assessment criteria.
Reduction in CRP level of the patient.
Reduction in ESR level of the patient.  		 Ist- 0 Day.
IInd - After the completion of trial.
IIIrd- 10 days after Basti karma 
 
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   N/A 
Date of First Enrollment (India)   01/01/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Vatarakta displays characteristics of modern-day gouty arthritis. Crystal arthropathy known as gouty arthritis is typically seen in middle-aged and older men and postmenopausal women. In 1848, Sir Alfred Garrod connected hyperuricemia to gout. The primary symptoms of hyperuricemia, a metabolic precursor of gout, are pain and swelling in the metatarsophalangeal joint and other major joints. The symptoms of gout include excruciating pain, warmth, redness, and tenderness in the joints as well as sensitivity to touch. Biochemically, gout is defined by extracellular fluid urate saturation, which is reflected in hyperuricemia in the blood, with urate concentrations in the plasma or serum above 6.0 mg/dL (or 400 micromol/L), which is the approximate limit of urate solubility. Primary Objective: To assess the effect of Bodhivriksha kashaya Basti karma in the reduction of Sr. Uric Acid level. patient assessment done according to criteria, if fit for trial and consent taken and proceeds with intervention according to patient group. 
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