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CTRI Number  CTRI/2022/05/042346 [Registered on: 02/05/2022] Trial Registered Prospectively
Last Modified On: 28/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A survey study of the causes of sciatica from the common causes of vatavyadhi w.s.r to ayurvedic siddhant. 
Scientific Title of Study   Cross sectional study of Hetu of Gridhrasee from Samanya Hetu of Vatavyadhi with special reference to Hetu Siddhant 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Pranjali Ramkrushna Hingane 
Designation  MD Scholar Ayurved Samhita and Siddhant (Ayurved) 
Affiliation  Sumatibhai Shah Ayurved College, Hadapsar, Pune  
Address  OPD no.02,Sane Guruji Arogya Kendra, Malwadi road ,Hadapsar Pune, Department of Ayurved Samhita and Siddhant,MAMs Sumatibhai Shah Ayurved College, Hadapsar, Pune Pune Maharashtra 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  7066941295  
Fax    
Email  pranjalihingane123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vd Nilesh Kulkarni 
Designation  H.O.D., Professor 
Affiliation  Sumatibhai Shah Ayurved College, Hadapsar, Pune  
Address  OPD no.02,Sane Guruji Arogya Kendra, Malwadi road ,Hadapsar Pune, Department of Ayurved Samhita and Siddhant,MAMs Sumatibhai Shah Ayurved College, Hadapsar, Pune Pune Maharashtra 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  8805335512  
Fax    
Email  vd.nilesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vd Nilesh Kulkarni 
Designation  H.O.D., Professor 
Affiliation  Sumatibhai Shah Ayurved College, Hadapsar, Pune  
Address  OPD no.02,Sane Guruji Arogya Kendra, Malwadi road ,Hadapsar Pune, Department of Ayurved Samhita and Siddhant,MAMs Sumatibhai Shah Ayurved College, Hadapsar, Pune Pune Maharashtra 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  8805335512  
Fax    
Email  vd.nilesh@gmail.com  
 
Source of Monetary or Material Support  
Department of Ayurved Samhita and Siddhant,Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune. 
 
Primary Sponsor  
Name  Sane Guruji Arogya Kendra 
Address  Department of Ayurved Samhita and Siddhant,Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune. 
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 Pranjali Hingane  Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune.  Opd no.02,Department of Kaychikitsa ,Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune.
Pune
MAHARASHTRA 
7066941295

pranjalihingane123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: GRUDHRASI, (2) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Having lakshana of Gridhrasee
1.Ruk, Toda, Stambha and Muhu-spandana
2.pain starts at Sphik and then radiates to Kati, Prishtha, Uru, janu, jangha, Pada in order
3.Sakthik-shepa-nigraha
4.pain in Payu 
 
ExclusionCriteria 
Details  1) Amavata
2) Kroshtukshirsh
3) Vatarakta
4) Pregnant Women
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
It would be proved that the common etiological factors for Vata Prakopa are same as the etiological factors of the disease Gridhrasee. Parameter will be assessed in the form of questioner and case record form.  The day first would be the day of the inclusion of the patient on which he/she will be interviewed in this cross sectional study. Parameter will be assessed in the form of questioner and case record form.
 
 
Secondary Outcome  
Outcome  TimePoints 
To study the Hetu of Gridhrasee and Vatavyadhi Hetu in details. and to find correlation between them.  Total duration of the study will 18 month. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   05/05/2022 
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   Ayurveda has wider concepts focusing on findings the factual cause of Vyadhi thus emphasize on elimination of that cause to prevent its recurrence and treating then right from roots.
Evaluating the root cause of any problem is halfway of solving it. In medical science immense stress is given to find out, main causative factor. So, finding the root cause as per mention by Maharshi in our Ayurvedic texts and get rid of them that is Nidanparivarjana is important. People falls sick not because of any infection alone, But also due to three primary cause namely, Asatmya Indriyartha Samyog, Pragynaparadham and Parinam , these underlyine cause upset the fine balance among the bioregulating factor of the body – Vata ,Pitta ,Kapha and make the individual fall prey to opportunistic disease.
So, this study is planned to search and correlate the Hetu of Vatavyadhi which found in Gridhrasi specially in today’s era. So that it could be ignored from practising and prevention can be done from this attempt we can minimize the Nidan of Gridhrasi and Swasth Rakshanam motive of Ayurveda can be achieved. Hence it is necessary to study this thoroughly.

 
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