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CTRI Number  CTRI/2024/07/069970 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 29/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Intake of taila medicated with Madhuyashtyadi drugs followed by evacuation of bowels in Rheumatoid Arthritis 
Scientific Title of Study   Effect of Madhuyashtyadi taila Snehapana followed by Virechana in 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 Shikha V M 
Designation  P G Scholar,Department of Panchakarma 
Affiliation  Government Ayurveda Medical College and Hospital 
Address  OP No.1,deparertment of panchakarma ,Government Ayurveda Medical College and Hospital,Pulimoodu junction Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9048544319  
Fax    
Email  shikhavm17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shikha V M 
Designation  P G Scholar,Department of Panchakarma 
Affiliation  Government Ayurveda Medical College and Hospital 
Address  OP No. 1,department of panchakarma,Government Ayurveda Medical College and Hospital,Pulimoodu junction Thiruvananthapuram


KERALA
695001
India 
Phone  9048544319  
Fax    
Email  shikhavm17@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manju P S 
Designation  Associate Professor,Department of Panchakarma 
Affiliation  Government Ayurveda Medical College and Hospital 
Address  OP No.1,department of panchakarma,Government Ayurveda Medical College and Hospital,Pulimoodu junction Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9847317295  
Fax    
Email  manjumahesh1977@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram,695001,India 
 
Primary Sponsor  
Name  Dr Shikha V M 
Address  Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram,695001,India 
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 Shikha V M  Government Ayurveda Panchakarma Hospital,Poojappura,Thiruvananthapuram  In Patient Department of Panchakarma, Government Ayurveda Panchakarma Hospital,Poojappura
Thiruvananthapuram
KERALA 
9048544319

shikhavm17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee(IEC) Govt Ayurveda College Thiruvananthapuram,Kerala,India  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: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-acCasnehaH, अच्छस्नेहः (Procedure Reference: charaka chikitsa 29, Procedure details: In the morning after the digestion of previous meal the participant should be seated comfortably and tie the eye with cotton and gauze piece.Madhuyashtyadi taila mezhukupakam heated and melted was administered. after giving taila eye bandage should be removed and give yusha as an anupana.then ask the patient to wash the face and mouth with hot water to remove the upalepatva.Dose of sneha is calculaed based on agni and koshta.According to achrya charaka for shodhana purpose sneha should be taken in madhyama matra (to be digested in 12 hours).first we have to give the sneha in hraseeyasi matra.After observing time taken for digestion on first day the dose for second day is calculated.After attaining the madhyama matra the dose should be continued upto attaing samyak snigdha lakshana. 3 days gap should be given after snehapana.during these days sarvanga abhyanga with pinda tailam and ooshma sweda should do for 15 minutes in morning )
(1) Medicine Name: Madhuyashtyadi Tailam, Reference: Ashtanga Hrdaya Chikitsa Sthana 22, Route: Oral, Dosage Form: Taila, Dose: 25(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Participants satisfying revised ACR/EULAR criteria for Rheumatoid Arthritis
2)Participants with RA factor positive 
 
ExclusionCriteria 
Details  1)Participants with major systemic illness
2)Those who have undergone surgical treatment in affected joints
3)Participants not fit for snehapana and virechana as per ayurvedic classics 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in the disease activity score measured by DAS 28 scale   0th day,6th day,17th day,23rd day and 47th day 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in RA factor, ESR,CRP measured by lab investigations  0th day and 47th day 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   20/07/2024 
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  

Rheumatoid arthritis is a chronic inflammatory disorder.It is an autoimmune disorder which occurs when your immune system mistakenly attacks your own body tissues.Rheumatoid arthritis affects the lining of the joints causing a painful swelling that can eventually result in bone erosion and joint deformity. Due to its similar presentations it can be correlate with vatarakta of our classics. The treatment principle of vatarakta includes proper snehana followed by mrdu virechana.Madhuyashtyadi taila mentioned in Ashtanga hrdaya vatarakta chikitsa is an important yoga mentioned in  vatarakta chikitsa.The objectives are to determine the effect of Madhuyashtyadi taila  snehapana in arohanakrama upto samyak snigdha lakshana followed by virechana in  reducing the disease activity score measured by DAS 28 and To determine the effect of shodananga snehapana with madhuyashtyadi taila administered in arohanakrama upto samyaksnigdha lakshana followed by virechana in reducing the haematological parameters like RA factor,CRP,ESR in rheumatoid arthritis.Study design is an experimental study with pre-post test without control group. Participants aged 20-60 years registered in the IPD of government ayurveda panchakarma hospital, poojappura, thiruvananthapuram diagnosed to have rheumatoid arthritis and satisfying inclusion criteria will be selected. The base line data will be collected through interview, laboratory investigations and observations. After collecting base line data, detailed history and examination will be done using clinical case proforma.  A total of 20 participants will be selected by consecutive sampling and they were subjected to deepana pachana for 5 days using amrthotharam kashayam 48ml bd before food and shaddharana choorna 6g bd with kashayam and panchakola choornam 12g at 11 am along with takra(anupana). After samyakrookshana lakshana attained snehapana will start with Madhuyashtyadi taila in arohanakrama.The snehapana should be stopped while attained samyak snigdha lakshana. After that abhyanga with pinda thailam and ooshma sweda will  be administer for 3 days. Then on the next day virechanam with nimbamrtadi erandatailam should be done. The participants will be assessed on 0thday, before snehapana(6thday) ,after virechana(17thday),on 23rdday and after follow up with regards to changes in  subjective parameters . RA factor ,CRP,and ESR will be assessed before treatment (0thday) and after follow up(47th day).Depending upon the distribution of variables, it will be analysed using Wilcoxon’s signed rank test or paired t test or anova test.

 
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