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CTRI Number  CTRI/2018/03/012511 [Registered on: 12/03/2018] Trial Registered Retrospectively
Last Modified On: 08/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical study on the effect of treatment of Amvata ( all joint pain) and effect of regular purgation ,oral intake of medicated Ghrita and Amritadi guggulu(oral medication) in the management of Amavata(RA)  
Scientific Title of Study   A comparative clinical study on the effect of treatment as per Chikitsasutra Nitya Virechana Indukant Ghrita and Amritadi guggulu in Amavata w.s.r. to Rheumatoid Arthritis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ujwala hivale  
Designation  Phd Scholar 
Affiliation  National Institute of Ayurveda  
Address  Department of Panchakarma National Institute of Ayurveda Madhav Vilas Palace Jorawarsingh Gate Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9887507329  
Fax    
Email  ujwala.hivale27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gopesh Mangal 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda  
Address  Department of Panchakarma National Institute of Ayurveda Jorawarsingh Gate Department of Panchakarma National Institute of Ayurveda Madhav Vilas Palace Jorawarsingh Gate Jaipur RAJASTHAN

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ujwala hivale 
Designation  Phd Scholar 
Affiliation  National Institute of Ayurveda  
Address  Department of Panchakarma National Institute of Ayurveda Madhav Vilas Palace Jorawarsingh Gate

Jaipur
RAJASTHAN
302002
India 
Phone  9887507329  
Fax    
Email  ujwala.hivale27@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda Madhav Vilas Palace Amer Road Jorawarsingh Gate Jaipur 302002 
 
Primary Sponsor  
Name  National Institute Of Ayurveda 
Address  National Institute Of Ayurveda Madhav Vilas Palace Amer Road Jorawarsingh Gate Jaipur 302002 
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 
Ujwala Hivale  National Institute of Ayurveda Jaipur  Dept of Panchkarma Madhav vilas palace 302002
Jaipur
RAJASTHAN 		 9887507329

ujwala.hivale27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalEthicsCommetteeNationalInstituteof Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Diagnosed patients of Amavata on the basis of clinical features as per Classical Ayurveda textbook and according to criteria of ACR ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A - Chitsasutra of Amavata  Group A Langhana (Laghu Bhojana) Swedana (Valuka Sweda) and oral administration of Tikta Katu Deepana drugs like Musta Shuntthi Indrayav and Guduchi 5 gm three times in a day for 7 days Virechana karma Snehapan Murchita Tila Taila (about 500ml per patient) As per Agni and Koshtha Till Samyak Snigdha Lakshana obtained (about 4 to 5 days)Then bahya abhyanga with Dashmool taila and mridu bashpa swedana done for 4 days Virechana Yoga (oral administration) Triphala Kwatha 100ml Trivrit Churna 10gm Kutaki Churna 10gm Eranda Taila 50ml then after 8 days Snehapana with Indukant Ghrita ( 20 ml once a day) for 7 days Erandamooladi Niruha Basti for 3 days(administration through anal rout) Erandmooladi Niruha Basti kwath - 480 ml Madhu - 80ml Saindhav lavan- 5 gms Sneha (Dashmoola taila)120ml Kalka (Putiyavanyadi Kalka) 30 gms Dashamoola taila Anuvasana For 5 days 60 ml duration of procedure of group A is 45 days and 45 days follow up total duration of trial is 3 month  
Intervention  Group B langhan valuka Swedana oral administration of Tikta katu Deepan drugs Nitya virechana and Amritadi guggulu  30 patients subjected to langhana(laghu bhojana) valuka swedana oral administration of tikta katu deepana(Musta Shunthi Indrayava and Guduchi sama bhaga churna 5 gm) for 7 days followed by Nitya virechana with oral administration of 10 ml Eranda Taila for 7 days followed by snehapana with indukanta Ghrita for 7 days followed by oral administration of Amritadi guggulu (500 mg tab) 2 tab three times a day for 15 days with luke warm water duration for procedure 30 days 
Comparator Agent  Group c oral administration of Amritadi Guggulu   30 patients will be subjected to langhana(laghu bhojana) valuka swedana oral administration of tikta katu deepana(Musta Shunthi Indrayava and Guduchi sama bhaga churna 5 gm) for 7 days followed by oral administration of Amritadi guggulu (500 mg tab) 2 tab three times a day for 30 days with luke warm water duration for procedure 37 days  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Prediagnosed case of Amavata (RA) with chronicity upto 10 year
Patient fit for Valuka Swedana Virechana Karma Snehapana and Basti Karma
 
 
ExclusionCriteria 
Details  Age below 16 years and above 60 years of either sex
Chronicity more than 10 years
Patients with severe crippling deformities extremely reduced joint space bone deformity
Any associated cardiac disease pulmonary tuberculosis DM Malignant hypertension renal function impairment Patient not fit for Valuka Swedana Virechan karma snehpan and Basti Karma
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in subjective and objective parameter  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the comparative efficacy of the treatment in different groups  3 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   22/06/2017 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 19/02/2018 
Estimated Duration of Trial   Years="0"
Months="8"
Days="7" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   No 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Rheumatoid Arthritis is on of the common debilitating disease it is categorized under autoimmune disorder along with locomotor  system , it is also affecting the cardio vascular , nervous respiratory and excretory system  of the body. Rheumatid Arthritis sometimes  progress relentlessy to joint destruction  and crippling .Disease modifying anti rheumatic drug (DMARD) are associated with several adverse effects   In Ayurveda based on clinical manifestations there is a close resemblance between Amavata and Rheumatoid Arthritis.Amavata described in Ayurveda,which is characterized with Angamarda (Bodyache),Aruchi (Anorexia),Trishna(thirst),Alasya(Lethargy),Gaurav (heaviness in the body),Jwara(Fever),Apaka (indigestion),Shunata (Swelling),Sandhishula (pain in joints),Stambha(Stiffness) etc  Ayurveda though its holistic approach and radical treatment like Panchakarma which corrects the basic pathology by eliminating the chief causative factors . Panchakarma not only cures the disease but also maintains total health of the body . The study was planned The study was  conducted on 90 clinically diagnosed cases of Amavata from OPD and IPD of dept.Panchakarma National Institute of Ayurveda, Patients were randomly divided into three group viz  group A Sequential employment of langhana, valuka  swedana,tikta katu deepana, virechana karma, snehapana, Basti karma in 30 patients group  B 30 patients were  subjected to langhana(laghu bhojana), valuka swedana, tikta katu deepana(Musta,Shunthi, Indrayava and Guduchi sama bhaga churna) for 7 days followed by Nitya virechana with 10 ml Eranda Taila for 7 days followed by snehapana with indukanta Ghrita for 7 days followed by oral administration of Amritadi guggulu (500 mg tab) 2 tab three times a day for 15 days with luke warm water. Group c  30 patients were  subjected to langhana(laghu bhojana), valuka swedana, tikta katu deepana(Musta,Shunthi, Indrayava and Guduchi sama bhaga churna) for 7 days  with oral administration of Amritadi guggulu (500 mg tab) 2 tab three times a day for 30 days with  warm water Written consent was taken from patient before starting trial Assisment was done before and after treatment and after follow up period. 

 

  
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