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CTRI Number  CTRI/2017/08/009420 [Registered on: 21/08/2017] Trial Registered Retrospectively
Last Modified On: 11/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [nil]  
Study Design  Single Arm Study 
Public Title of Study   Effect of arka patra sweda in katigrha 
Scientific Title of Study   Clinical study to evaluate the efficacy of Arka patra sweda in the management of Kati Graha 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr mayur nagar 
Designation  second year pg scholar 
Affiliation  sri dharmasthala manjunatheshwara college of ayurveda and hospital hassan 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road Thannirulla Hassan Karnataka

Hassan
KARNATAKA
573201
India 
Phone  8095997047  
Fax  08172-256464  
Email  drmayur23vaidya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashvini KumarM 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Department of Panchakarma Sri dharmasthala manjunatheshwara college of ayurveda and hospital BM road Thannirulla Hassan Karnataka

Hassan
KARNATAKA
573201
India 
Phone  9448705660  
Fax  08172-256464  
Email  ashvinipanchakarma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashvini KumarM 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Dr. Ashvini Kumar.M Professor Department of Panchakarma Sri dharmasthala manjunatheshwara college of ayurveda and hospital BM road thannirulla hassan karnataka

Hassan
KARNATAKA
573201
India 
Phone  9448705660  
Fax  08172-256464  
Email  ashvinipanchakarma@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheswhwara College Of Ayurveda And Hospital, B M ROAD, TAMMIRUHALLA HASSAN 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Sri dharmasthala manjunatheshwara college of ayurveda and hospital BM road thannirulla hassan karnataka  
Type of Sponsor  Research institution and hospital 
 
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 Mayur Nagar  Sri dharmasthala manjunatheshwara college of ayurveda and hospital   Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Opd No 14, Department Of Panchakarma, Bm Road Thannirulla Hassan Karnataka
Hassan
KARNATAKA 
8095997047
08172-256464
drmayur23vaidya@gmal.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Dharmasthala Manjunatheshwra college of ayurveda and Hospital Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  katigraha,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arka patra sweda continuosly for three consecutive days  15-18 no of fresh medium size arka patras are well cleaned and are kept side by side without leaving gap on kora cloth of 25" length, 5" breath and then cloth and leaves are rolled together and tied from base with tag of 16" length and arka patra sweda is given for three consecutive days. after completion of treatment patient will be asked to take hot water bath. 
Comparator Agent  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  the patients who are fit for swedana
in between age group of 20-70 years of either sex will be selected 
 
ExclusionCriteria 
Details  patients who are having low back ache due to any infection, organomegaly, viscerogenic.
patients with history of trauma.
post surgical backache 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
progress will be noted on basis of assesment parameters before and after traetment.
subjective criteria samyak swedana lakshanas
objective parametes - pain , stiffness , restricted movements of spine such as- flexion, extension, left lateral movement, right lateral movement, rotating movement
walking time 
3 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
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   Phase 2 
Date of First Enrollment (India)   01/04/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   will be done in due course of study 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Svedana is one of the Shadvidha Upakram and is indicated in the management of various Vatavyadhi’s  and as well as  for Vata-Kaphaja disorders .Svedana Karma can be performed by various methods. Arkapatra Svedana is one among the modalities of Svedana and  practiced  by traditional Ayurveda doctors

         In Katigraha the Vedana, Stambha and Cheshtastambha are present in Kati Pradesha may be caused by Kevala Vata or Saama Vata. The symptoms of Saama Vata is Vedana, Toda, Stambha.  

Svedana Karma plays a major role in alleviating the pain and stiffness of joints. Svedana relieves stiffness, heaviness and coldness of the body and it induce the body sweat. Svedana is of three types viz. Rooksha, Snigdha and Snigdha Ruksha Sveda Rooksha Svedas are generally opted in the treatment of disorders caused by Vata and kapha Doshas.

                     In Katigraha the Shoola and restricted movements are present in whole of Kati Pradesha, i.e. in between Uraha and Nitamba (lumbo sacral region). In other hand Low back pain is a chronic condition characterized by a persistent dull or sharp pain per the lower back. It may be also associated with burning, stiffness, numbness or tingling with the pain. The most important symptoms of non-specific low back pain are pain and disability.

Arka(Calatripis procera) patra latex possess Tikta Rasa majorly and  little amount of Lavana Rasa, Singhdha and Laghu guna, Ushna Veerya­­­­ and leaves are Laghu Ruksha and Tikshna in Guna and having Vatahara, Vishaghana, Rechana and Dipana  properties. Saindhava is aleviator of all three dosas and does not cause burning sensation. Ghee alleviates Vata, Pitta, toxic conditions ,cold in potency and best of all the unctuous substances.  By virtue of all above properties of Arka Patra , Arka Ksheera ,Saindhava and Ghee  Arka Patra  sveda may reduce the pain in affected area.

 

 In this study 15 to 18 number of fresh Arka Patras are well cleaned and are kept side by side without leaving gap on Kora cloth of 25 inches length x 5 inches breadth and then cloth and leaves are rolled together and tied from the base with tag of 16 inches length.  In the morning, Patients will be given 6 grams of Shunthi choorna along with luke warm water in empty stomach Prepared Arka Patra bundle is cut from the base and is  heated on a hot pan with ghee and Saindhava Lavana . Hot  leaves are then tapped on Kati Pradesha. Once the temperature of  the leaves is lost, again  they are cut, heated and tapped.  This procedure is to be repeated till the Samyak Svedana  Lakshanas are seen or upto 20 minutes. After completion of treatment, patient will be asked to take hot water bath.

The numerical data will be assessed with Student paired t-test. Ordinal data will be assessed with Friedmen’s test followed by Post Hoc Analysis with Wilcoxon signed rank test with Bonferroni correction applied. Changes observed (p<0.05) will be considered as significant.

 

 

 
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