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CTRI Number  CTRI/2024/07/070997 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 29/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A clinical intervention to evaluate the efficacy of Panchakola gruel Vaishwanara Powder Enema followed by Nirgundi ghana tablet and Panchakola gruel Vaishwanara Powder Enema followed by Simhanada Guggulu in Rheumatoid Arthritis 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Panchakola Yavagu Vaishwanara Churna Basti followed by Nirgundi Ghana Vati and Panchakola Yavagu Vaishwanara Churna Basti followed by Simhanada Guggulu in Amavata visàvis 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  NIKITA RATHEE 
Designation  POST GRADUATE SCHOLAR  
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Center  
Address  Room number 2 Department of Kyachikitsa Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Center 10 Pipeline Road RPC Layout Vijayanagar Bangalore
Room number 2 Department of Kayachikitsa Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Center 10 Pipeline Road RPC Layout Vijayanagar Bangalore
Bangalore
KARNATAKA
560104
India 
Phone  7015481142  
Fax    
Email  nikitarathee2501@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MANJUNATHA ADIGA 
Designation  PROFESSOR 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Center  
Address  Room number 2 Department of Kayachikitsa Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Center 10 Pipeline Road RPC Layout Vijayanagar Bangalore
Room number 2 Department of Kayachikitsa Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Center 10 Pipeline Road RPC Layout Vijayanagar Bangalore
Bangalore
KARNATAKA
560104
India 
Phone  9035715798  
Fax    
Email  adiga.manjunatha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MANJUNATHA ADIGA 
Designation  PROFESSOR 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Center  
Address  Room number 2 Department of Kayachikitsa Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Center 10 Pipeline Road RPC Layout Vijayanagar Bangalore
Room number 2 Department of Kayachikitsa Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Center 10 Pipeline Road RPC Layout Vijayanagar Bangalore
Bangalore
KARNATAKA
560104
India 
Phone  9035715798  
Fax    
Email  adiga.manjunatha@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor
Modification(s)  
Name  NIKITA RATHEE 
Address  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Center 10 Pipeline Road RPC Layout Vijayanagar Bangalore 
Type of Sponsor  Private 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 KIRAN M GOUD  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Center   Department of Kayachikitsa Room Number 2
Bangalore
KARNATAKA 
9845109556

kiranmgoud@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre   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: Charaka samhita Siddhi sthana 10/13-14, Procedure details: Patients will be subjected for Sthanika Abhyanga with Moorchita tila taila over abdomen groin buttocks and thigh region Followed by Sthanika Nadi Sweda Basti will be administered in Yoga basti pattern for 8 consecutive days Niruha Basti - Vaishwanara Churna Basti Anuvasana Basti - Brihata Saindhavadi taila The patient will be made to lie down in left lateral position and basti will be administered )
(1) Medicine Name: Vaishwanara Churna , Reference: Chakrapani Dutta , Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 576(ml), Frequency: od, Duration: 8 Days
(2) Medicine Name: Nirgundi ghana vati, Reference: Bhavaprakasha , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: tds, Duration: 15 Days
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charaka samhita Siddhi sthana 10/13-14, Procedure details: Patients will be subjected for Sthanika Abhyanga with Moorchita tila taila over abdomen groin buttocks and thigh region Followed by Sthanika Nadi Sweda Basti will be administered in Yoga basti pattern for 8 consecutive days Niruha Basti - Vaishwanara Churna Basti Anuvasana Basti - Brihata Saindhavadi taila The patient will be made to lie down in left lateral position and basti will be administered)
(1) Medicine Name: Vaishwanara Churna, Reference: Chakrapani Dutta, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 576(ml), Frequency: od, Duration: 8 Days
(2) Medicine Name: Simhanada Guggulu, Reference: Chakrapani Dutta, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: tds, Duration: 15 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients with lakshanas of Amavata

2.Patients of either gender within age group of 18 years to 60 years

3.Patients with Amavata who are fit for Basti Karma
 
 
ExclusionCriteria 
Details  1.Chronicity of more than 5 years

2.Patients of Amavata having any deformity

3.Patients diagnosed with other systemic disorders interfering with the course of treatment

4.Pregnant & lactating women diagnosed with Amavata
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To see the effect of both the drugs in reducing the symptoms of Amavata and any changes in investigations if present  1.Before treatment baselinen
2.8th day - after panchakola yavagu
3.16th day - After Basti
4.After 30 days - After oral medicines 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 
Date of First Enrollment (India)   15/09/2025 
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="5" 
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  

Rheumatoid Arthritis is one of the very common ailments in every age group and Indian as well as western population in recent period. Physical limitations in work, pain, fatigue which in turn affects the mental health are some issues relating to it. Many clinical drug trials and researches have been carried out, yet the management of this disease is insufficient in other system of medicine. So due to much prevalence in society and lack of effective treatment, the disease is being chosen for the study.

Rheumatoid Arthritis is a chronic disease of unknown cause, characterized by persistent inflammatory synovitis, usually involving peripheral joints symmetrically. Common symptoms of Rheumatoid Arthritis include morning stiffness of the joints for more than 30 minutes, fatigue, fever, weight loss, and rheumatoid nodule in chronic phase.

Rheumatoid Arthritis has been common and distressing among all joint problems in recent days. RA is affecting 0.5-1% of population worldwide which is increasing with the increasing population. It is more common in females than in males, female to male ratio is 3:1.

In India, the prevalence of rheumatoid arthritis is 0.75 percent. The onset of disease is frequent between 30-50 years of age with 80% of patients developing the disease between 35-50 years of age.

In contemporary science glucocorticoids, DMARDS, NSAIDS and immunosuppressive treatments are used to treat Rheumatoid Arthritis which are effective in the preliminary stage but in long run may lead to many side effects.

In Ayurveda this disease is compared with Amavata. Ama and vata are vitiated simultaneously and manifestation of disease occurs mainly in joints of hasta, trika, pada, sira, gulpha, uru and janu. The main symptoms seen are Angamarda Aruchi, Trishna, Alasya, Shotha, Gouravam and Apaka.

 The disease involves Tridosha though Ama and Vata are the initiating factors in the pathogenesis. Acharya Chakrapanidutta has explained the principles in the treatment of Amavata. These are Langhana (fasting), Swedana (sudation), use of Tikta (bitter) and Katu (pungent) Rasa, Deepana (stimulating hunger), Virechana (purgation therapy) and Anuvasana basti (enema).

Modern science lacks proper treatment. Hence it is our duty being a holistic system of medicine to provide effective, as well as cost effective treatment with less adverse effects.

Panchakola siddha yavagu is said to have deepana ,pachana and shulaghana properties. This preparation is taken for deepana and amapachana and relieve the symptoms of patient initially.

Basti is considered as the best in pacifying Vata Vyadhi, so basti by virtue of its versatility and impact is called Ardha Chikitsa. So, it’s a effort to check the effect of Shodhan Chikitsa and Shamana Chikitsa in treatment of Amavata which is thought to do correction of metabolism along with providing symptomatic relief.

Vaishwanara Churna Niruha Basti main ingredients are saindhava , sneha, churna kalka, ushnajala and dhanyamla. Churna consists of saindhava lavana, yavani, ajamoda, haritaki which are having vata kaphahara, deepaniya, shothahara and amahara properties. All these drugs perform Amapachana at Dhatu level, relieves agnimandya. Thus the Samprapti vighatana of the Roga is initiated.

Simhanada Guggulu is Kapha-vatahara, Pittavardhaka, Agnideepaka and Amapachaka. The contents of Simhanada Guggulu have analgesic and anti-inflammatory properties and it is believed to modify the immune response to autoantigens.

Nirgundi has Amavatahara property as said in Bhavaprakasha, considering this Nirgundi Patra Ghana vati is selected as Shamana Aushaudha. Tikta and Katu Rasa present in Nirgundi possesses the antagonistic properties to that of Ama and Kapha which are the chief causative factors in this disease. Due to Agnivardhaka property, this has potential to increase digestive power which also digests Ama and reduces excessive production of Kapha. Being Tikshna and Ushna it also helps alleviate vitiated Vata and reduces Srotorodha and pain. Hence, Nirgundi helps controls Ama and Vata and also minimize the process of pathogenesis of amavata.

 

Many studies are done on Nirgundi Ghana Vati and Simhanada Guggulu separately and both are found to be effective in Amavata. Hence, keeping Simhanada Guggulu as standard drug, this study aims at comparing both these formulations for the efficacy in Amavata along with effect of Panchakola Yavagu and Vaishwanara Churna Basti common in both groups.

 
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