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CTRI Number  CTRI/2024/08/072979 [Registered on: 27/08/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial will be done to know the effect of Atasi Taila Matra Basti in the Management of Janusandhigata Vata 
Scientific Title of Study   A Randomized Controlled Trial to Evaluate the Effect of Atasi Taila Matra Basti in the Management of Janusandhigata Vata 
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 Pratiksha Rajnath Yadav 
Designation  MD Scholar Panchakarma 
Affiliation  Sumatibhai Shah Ayurved Mahavidyalaya 
Address  Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO. 6 Department of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  9920223268  
Fax    
Email  pratikshayadav3268@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Vandana Avhad 
Designation  Assistant Professor Of Department Of Panchakarma 
Affiliation  Sumatibhai Shah Ayurved Mahavidyalaya 
Address  Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO. 6 Department of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  9890608788  
Fax    
Email  drvandanapalve@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pratiksha Rajnath Yadav 
Designation  MD Scholar Panchakarma 
Affiliation  Sumatibhai Shah Ayurved Mahavidyalaya 
Address  Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO. 6 Department of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  9920223268  
Fax    
Email  pratikshayadav3268@gmail.com  
 
Source of Monetary or Material Support  
Department of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 
 
Primary Sponsor  
Name  Sane Guruji Arogya Kendra Malwadi Hadapsar Pune  
Address  Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 41102 
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 Pratiksha Rajnath Yadav  Sane Guruji Arogya Kendra   OPD No.6 Department of Panchakarma Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA 		 9920223268

pratikshayadav3268@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAMs Sumatibhai Shah Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Matra (Procedure Reference: Agnivesha, Charaka, Dridabala,Vidyamanorama, siddhisthana, chapter 28,verse, Procedure details: Matra Basti is a type of Sneha Basti ( Fat Enema). It has received vast recognition for its multifaceted application & as it is convenient to use and can be administered at any time of the day. It doesn’t cause any complication and can be given on daily basis . In Sneha Basti/ Anuvasan Basti medicated Oil/ Ghee (Lipids) are used wherein Anuvasan means “To Stay”. Matra Basti is half the dose of Anuvasan Basti i.e. Half of 12 tola which is 6 tola . Matra Basti stays in the colon for maximum 12 hours and can induce all beneficial results. In earlier days the bladder of Goat was being used for administration of enema while nowadays Plastic enema pot and syringes are being used for the procedure. Duration of procedure- Treatment will be given for 8 days)
(1) Medicine Name: Atasi taila, Reference: Chunekar K.C Edited Bhavprakash Nighantu- Indian Materia Medica, Tailavarga, Atasitaila 19/17-19, Chaukhamba Bharati Academy, Edition 2010 pg. no 765, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 8 Days
2Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Agnivesha, Charaka, Dridabala,Vidyamanorama, siddhisthana, chapter 28,verse, Procedure details: Matra Basti is a type of Sneha Basti ( Fat Enema). It has received vast recognition for its multifaceted application & as it is convenient to use and can be administered at any time of the day. It doesn’t cause any complication and can be given on daily basis . In Sneha Basti/ Anuvasan Basti medicated Oil/ Ghee (Lipids) are used wherein Anuvasan means “To Stay”. Matra Basti is half the dose of Anuvasan Basti i.e. Half of 12 tola which is 6 tola . Matra Basti stays in the colon for maximum 12 hours and can induce all beneficial results. In earlier days the bladder of Goat was being used for administration of enema while nowadays Plastic enema pot and syringes are being used for the procedure. Duration of procedure- Treatment will be given for 8 days)
(1) Medicine Name: Tila taila, Reference: Sharma Priyavrat,Dravyaguna Vigyan, vol.-1, Chaukhamba Bharati Academy,reprint-2015, chapter2, page number-120., Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 8 Days
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients having classical symptoms of
Janusandhigata Vata.
Basti arha
Gender- male and female.
Age-25 to 70 years 
 
ExclusionCriteria 
Details  Patients with Congenital Structural and Functional Deformity
Patients suffering from any type of Joint Deformities or Systemic Disorder which
can interfere with the treatment of Janusandhigata Vata
Pregnant women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Atasi Taila Matra Basti in the Management of Janusandhigata Vata  Treatment will be given for 8 days
Patients will be assessed on 0th day and then 8th day  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effectiveness of Atasi Taila Matra Basti to Tila Taila Matra Basti in management of Janusandhigata Vata where Tila Taila is considered gold standard & control group.  Treatment will be given for 8 days.
Patients assessment will be done on 0th day & 8th day 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   03/09/2024 
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   This is a randomized controlled trial to evaluate the effect of Atasi Taila Matra Basti in the management of Janusandhigata Vata.In this study two groups will be drawn through lottery method.One group will receive Tila Taila Matra Basti which is considered gold standard and is the control group. Other group will receive Atasi Taila Matra Basti to evaluate the effectiveness of the same in management of Janusandhigata Vata. Both the groups will receive treatment for 8 days. Patients assessment will be done on 0th day and 8th day.Follow up will be done on 8th and 15th day respectively.Observations will be drawn from the outcome of the interest. 
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