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CTRI Number  CTRI/2024/08/072551 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 14/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to know the effect of Siddha basti and Siddha basti with valuka sweda in Amavata(Rheumatoid arthritis) 
Scientific Title of Study   An Open Label Double Arm Comparative Clinical Study On The Effect of Siddha Basti and Siddha Basti with Valuka Sweda in Amavata(Rheumatoid arthritis) 
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 Pranathi G Kashyap 
Designation  2nd Year PG Scholar 
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital 
Address  Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 15 and OPD 26 Anchepalya Bengaluru Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  8147329725  
Fax    
Email  pranathi.kashyap59@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Basavaraj G Saraganachari 
Designation  Professor and HOD 
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital 
Address  Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 15 Anchepalya Bengaluru Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  9448008022  
Fax    
Email  drbasugs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Basavaraj G Saraganachari 
Designation  Professor and HOD 
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital 
Address  Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 15 Anchepalya Bengaluru Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  9448008022  
Fax    
Email  drbasugs@gmail.com  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital Bengaluru 
 
Primary Sponsor  
Name  Dr Pranathi G Kashyap 
Address  Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 15 and OPD 26 Bengaluru Karnataka 560074 
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 Pranathi G Kashyap  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital  OPD 15 and OPD 26 Department of Panchakarma Bangalore KARNATAKA
Bangalore
KARNATAKA 
8147329725

pranathi.kashyap59@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Vangasena samhita basti karma adhikara, Procedure details: Siddha basti in the form of yoga basti for 8 days)
(1) Medicine Name: Siddha basti, Reference: Vangasena samhita basti karma adhikara, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 552(ml), Frequency: od, Duration: 8 Days
2Comparator ArmProcedure-piNDasvedaH, पिण्डस्वेदः (Procedure Reference: Charaka samhitha swedhadyaya, Procedure details: To assess the added effect, Sarvanga valuka sweda is done along with Siddha basti for 8 days in comparator group)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Amavata with features of Rheumatoid arthritis as specified in 2010 ACR-EULAR classification criteria.
2.Irrespective of serological negativity and positivity are included for the study.
3.Patients fit for Basti karma.
4.Patient of either gender with the age group 30 to 60 years.
5.Recent onset and less than or equal to 5 years of chronicity.
6.Considering disease activity and functional impairment STAGE-1, STAGE-2
7.Patients voluntarily willing to participate in the study and ready to sign consent form.
 
 
ExclusionCriteria 
Details  1.Patients with known case of uncontrolled hypertension and diabetes mellitus.
2.Patients with cardiac manifestations.
3.Patients diagnosed with other degenerative and inflammatory joint diseases, history of knee implants and total knee replacement surgeries.
4.Patients with the signs and symptoms of Pravruddha amavata21 with joint deformities STAGE-3, STAGE-4.
5.Active tuberculosis, Ulcerative colitis, Irritable bowel syndrome or other sever systemic and endocrine disorders.
6.Patients of Ano-Rectal disorders.
7.Pregnancy and lactating women.
8.Patients with cerebrovascular accident.
9.Patients who are receiving chemotherapy and radiotherapy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• Significant improvement in Sandhi shola (joint pain) measured using VAS(Visual analog scale)
• Significant improvement in Sandhi sthabdhata(morning stiffness) using Gradings
• Significant improvement in Sandhi shotha(joint swelling) using gradings
• Significant improvement in Tenderness using gradings
 
0th day(before treatment),9th day(after treatment) and 24th day(after treatment)
 
 
Secondary Outcome  
Outcome  TimePoints 
• Significant improvement in DAS 28Score
• Improved Quality of life related to joints.
 
0th day(before treatment), 9th day(after treatment) and 24th day(after treatment) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   02/09/2024 
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="1"
Months="6"
Days="0" 
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  

            In the present era, due to a sedentary lifestyle, consumption of incompatible food, hectic work schedules, improper physical activities, stress and many such reasons, individuals are prone to develop distressing clinical conditions which are mainly caused due to impaired digestion and metabolism. Amavata is one such crippling disease claiming maximum loss of human power where there is formation and deposition of Ama at all levels of body physiology.

                                                           

     The symptoms of Amavata have strong parlance with Rheumatoid arthritis observed as an autoimmune and a systemic inflammatory disease that is characterized by a progressive and disabling course with a prevalence rate of 0.24%  which has drastically increased up to 0.5% -1% over a decade, with a woman to man ratio of 3:1. It is 4-5 times higher in women under 50 years, but after 60 years the ratio becomes approximately 2:1 globally. Family studies indicate a genetic predisposition and patients with first-degree relatives possessing the auto antibody are found to have 2 - 1 times greater risk of developing severe arthritis than the general population.

 

      In contemporary science, NSAIDs, DMARD, immunosuppressants and Steroids are widely used which do only symptomatic relief with no cure but have high chances of developing co-morbidities. In Ayurveda, Siddha basti mentioned in Vangasena samhita and Valuka sweda mentioned in Yogaratnakara are mainly indicated for Amavata(Rheumatoid arthritis) as both the treatment modalities do vata kapha prashamana which is the main cause for the disease. Basti karma has been selected as it is the prime treatment for vata dosha not only in curative and preventive aspects of diseases but also in promotive aspects hence considered as chikitsardha by our Acharyas. Valuka sweda does kapha, shotha and shoolahara inturn subsides ama. Hence this study is undertaken to evaluate the effect of Siddha basti and the additive effect of Sarvanga Valuka sweda along with Siddha basti  in Amavata (Rheumatoid arthritis).

 
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