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CTRI Number  CTRI/2022/07/044264 [Registered on: 22/07/2022] Trial Registered Prospectively
Last Modified On: 15/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [curative]  
Study Design  Other 
Public Title of Study   A clinical study to assess selected physiological, haematological and biochemical changes in the body during dhanyamla dhara in 2 methods in Rheumatoid arthritis 
Scientific Title of Study   A Randomised Comparative Clinical Trial to assess selected Physiological, Haematological and Biochemical changes during Dhānyāmḻa Pariá¹£eka Sveda with classical and conventional method in 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 Rasna Karayil 
Designation  PG scholar 
Affiliation  Vaidyaratnam PS Varrier Ayurveda college Kottakkal  
Address  Department of panchakarma VPSV Ayurveda college Kottakkal Edarikode PO Malappuram 676501 Kerala

Malappuram
KERALA
676501
India 
Phone  9400805646  
Fax    
Email  krasna47@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jigeesh PP 
Designation  Proffessor and HOD in charge 
Affiliation  Vaidyaratnam PS Varrier Ayurveda college Kottakkal  
Address  Department of panchakarma VPSV Ayurveda college Kottakkal Edarikode PO Malappuram 676501 Kerala

Malappuram
KERALA
676501
India 
Phone  9447997436  
Fax    
Email  drjigeesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jigeesh PP 
Designation  Proffessor and HOD in charge 
Affiliation  Vaidyaratnam PS Varrier Ayurveda college Kottakkal  
Address  Department of panchakarma VPSV Ayurveda college Kottakkal Edarikode PO Malappuram 676501 Kerala

Malappuram
KERALA
676501
India 
Phone  9447997436  
Fax    
Email  drjigeesh@gmail.com  
 
Source of Monetary or Material Support  
VPSV Ayurveda college hospital, Kottakkal  
 
Primary Sponsor  
Name  VPSV Ayurveda college Kottakkal 
Address  VPSV Ayurveda college Kottakkal Edarikode PO Malappuram district Kerala 676501 
Type of Sponsor  Other [Aided 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 Rasna Karayil  VPSV Ayurveda college hospital Kottakkal  IPD Department of Panchakarma VPSV Ayurveda college hospital Kottakkal Edarikode po Malappuram 676051
Malappuram
KERALA 		 9400805646

krasna47@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IRB) Vaidyaratnam P.S.Varier Ayurveda college Kottakkal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pariSheka, परिषेक (Procedure Reference: Charaka samhitha, Procedure details: Dhanyamla dhara done after covering the body with cloth Duration 35 minutes)
(1) Medicine Name: Dhanyamla, Reference: Sahasrayogam, Route: Topical, Dosage Form: Dravaka, Dose: 6000(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-pariSheka, परिषेक (Procedure Reference: Charaka samhitha, Procedure details: Dhanyamla dhara done without covering the body with cloth Duration 35 minutes)
(1) Medicine Name: Dhanyamla, Reference: Sahasrayogam, Route: Topical, Dosage Form: Dravaka, Dose: 6000(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Aged 30 to 60 years
2.No discrimination of gender
3.Chronicity not more than 3 years
4.Patient willing to give written informed consent
5.Fit for dhanyamla parisheka sveda 
 
ExclusionCriteria 
Details  1.Known systemic inflammatory conditions other than RA
2.Known case of Malignancy
3.Largely or wholly incapacitated permitting little or no self care
4.Known Cardiovascular disorders (such as Coronary artery disease, Rheumatic heart
disease, Congenital heart disease and Cardiac myopathy)
5.Known Hepatic disorders and Endocrinal disorders
6.Those who are taking anti Rheumatoid drugs
7.Pregnant and lactating females.
8.Any other condition that may jeopardize the study. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Systolic and Diastolic Blood Pressure,Heart Rate, Pulse Rate , Oral temperature, Surface temperature, Body weight, Sweat rate, Total count, Differential
count, Hb, Serum urea, Serum creatinine, Serum electrolytes (Na+, K+, Cl-)
 		 SBP,DBP,body weight-Just before and after the procedure and 20 minutes after rest
HR,Oral temperature-Just before ,10 minutes after starting the procedure, just after the procedure & 20 minutes after the procedure
Surface temperature,PR-Just before the procedure10 minutes after starting the procedure, 20th minute, just after the procedure and 20 minutes after rest
Sweat rate-AT each day after procedure
TC,DC,Hb,Serum urea,Serum creatinine,Serum electrolytes-BT,AT
 
 
Secondary Outcome  
Outcome  TimePoints 
samyak swinna lakshana (seeta kshaya-Relief of coldness, Sula kshaya- relief of pain, gourava nigraha-relief of heaviness, mardava janana-softness of skin, sweda srava- sweat production,deeptagni- digestive power, vyadhi hani-relief of symptoms)

 		 Each day just after the treatment

 
Efficacy of dhanyamla parisheka sveda in reducing signs and symptoms of rheumatoid arthritis (pain, swelling, stiffness, warmth,tenderness)  Before starting of treatment and after completing the treatment(0th and 7th day)  
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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/ Phase 3 
Date of First Enrollment (India)   01/08/2022 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   A Randomised Comparative Clinical Trial to assess selected Physiological, Haematological and Biochemical changes during Dhānyāmḻa Pariá¹£eka Sveda in two groups with 18 participants in trial ( after covering the body with cloth, that is classical method) and controlled (without covering the body with cloth that is conventional method) group.The outcome will be measured using physiological parameters like systolic blood pressure,diastolic blood pressure, heart rate,pulse rate, oral temparature, surface temparature, body weight, sweat rate which will be done in specific intervals. Haematological parameters like TC,DC,Hb, and biochemical parameters like serum urea, creatine , serum electrolytes (BT and AT) will be  assessed .The samyak swinna lakshana in both group will be observed in each day after treatment.The efficacy of dhanyamla dhara in reducing signs and symptoms of Rheumatoid arthritis also will be assessed. 
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