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CTRI Number  CTRI/2024/12/078522 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 13/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study of anatomical involvement and changes in lumbo-sacral spine in patients of gridhrasi using lumbo-sacra 
Scientific Title of Study   A cross-sectional study of anatomical involvement and changes in lumbo-sacral spine in patients of vata-kaphajagridhrasi using lumbo-sacral MRI-scan(Magnetic Resonance Imaging) 
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 Prachi Dashendra Rahangdale 
Designation  PG Scholar 
Affiliation  PDEAS College of Ayurved And Research Centre 
Address  PDEAS College of ayurved and research centre rachana sharir department, ground floor,room no.1,sector 25,nigdi pune Maharashtra 411044 India
PDEAS College of ayurved and research centre rachana sharir department, ground floor,room no.1,sector 25,nigdi pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India 
Phone  8806691772  
Fax    
Email  prachirahangdale97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhuri Mahadar 
Designation  Associate professor 
Affiliation  PDEAS College of Ayurved And Research Centre 
Address  PDEAS College of ayurved and research centre rachana sharir department, ground floor,room no.1,sector 25,nigdi pune Maharashtra 411044 India
PDEAS College of ayurved and research centre rachana sharir department, ground floor,room no.1,sector 25,nigdi pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India 
Phone  9822002667  
Fax    
Email  drmadhuri75@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Madhuri Mahadar 
Designation  Associate professor 
Affiliation  PDEAS College of Ayurved And Research Centre 
Address  PDEAS College of ayurved and research centre rachana sharir department, ground floor,room no.1,sector 25,nigdi pune Maharashtra 411044 India
PDEAS College of ayurved and research centre rachana sharir department, ground floor,room no.1,sector 25,nigdi pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India 
Phone  9822002667  
Fax    
Email  drmadhuri75@gmail.com  
 
Source of Monetary or Material Support  
PDEAS college of ayurved and research centre nigdi pune, 411044,Maharashtra, India 
 
Primary Sponsor  
Name  PDEAS College of Ayurved And Research Centre 
Address  PDEAS College of ayurved and research centre rachana sharir department ground floor nigdi pune Maharashtra 411044 India 
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 Prachi Dashendra Rahangdale  Ayurved Rugnalaya And Sterling Multispeciality Hospital  OPD No. 117 , Kayachikitsa Department , Sector 27, Nigdi Pradhikaran , Pune , Maharashtra
Pune
MAHARASHTRA 		 8806691772

prachirahangdale97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chairperson Ethics Committe College of Ayurved And Research Centre Akurdi Pune 44  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G50-G59||Nerve, nerve root and plexus disorders. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Pre - diagnosed patients of vata-kaphaja gridhrasi who has done lumbosacral MRI-scan will be selected.
2.Age group of 30 to 70 years irrespective of sex, religion, marital status and
socio-economic status and occupation.  
 
ExclusionCriteria 
Details  1. Chronic patients like malignancy.
2. Known case of TB and HIV.
3. History of trauma of spine.
4. Patients contra-indicated for MRI-scan.14
5. Patients with congenital anamolies.
6. Post-Operated patients of lumbo-sacral spine and leg.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out structural involvement and changes in Lumbo-sacral spine in patients of
Vata-kaphaja Gridhrasi.
 		 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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)   26/12/2024 
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 Yet Recruiting 
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   The term ’Gridhrasi’ is derived from word ’Gridhra’ which means ‘Vulture’.

Here, the word Gridhrasi is suggestive of typical character of pain and also the gait of the patient (slightly tilted towards the affected side, affected leg in flexed position and other leg is extended). 

Gridhrasi is included in Vataja Nanatmajavyadhi and also considered as a Maharoga by acharya Charaka. 

According to aacharya Charak, 

स्फिक पुर्वाकटि पृष्ठोरुजानुजन्घा पदं क्रमात् | 
गृध्रसी : गौस्तंभ रुक तोदैर् गुह्नति स्पन्दते मुहु :| 
वाताद्वात कफात् तन्द्रा रवारोचकान्विता:|| 
                                                                        -च .चि .2853,54

The pain starts at sfika(gluteal region) and then radiates to kati(lumbar region), prushtha(posterior of thigh),uru(thigh),janu(knee), jangha(calf) and pada(foot) respectively . 


According to acharya Sushruta and ashtang Hridaya,

In Gridhrasi vata invades the kandaras of the ankle and toes and produces kshepan in the thighs.

Acharya Charaka and Bhavaprakasha has described 2 types of Gridhrasi-
1.Vataja
2.Vata-kaphaja

The above mentioned lakshanas of Gridhrasi are mainly seen and starts from Lumbo-sacral region and the structures which are involved in this region can be studied with the help of Lumbo-sacral MRI-scan.


 
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