FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075479 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 11/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic management of sciatica by rason saptak qwath. 
Scientific Title of Study   Randomized controlled clinical trial to evaluate the efficacy of Rasonsaptak kashaya in the management of Gridhrasi (Sciatica) 
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 Kedar Dandare 
Designation  PG Student Kayachikitsa 
Affiliation  CSMSS Ayurved Mahavidyalay 
Address  CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011
CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011
Aurangabad
MAHARASHTRA
431011
India 
Phone  8668331644  
Fax    
Email  kedardandare@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naresh Nimbalkar 
Designation  Associate Professor 
Affiliation  Chatrapati Shahu Maharaj Shikshan sanstha Ayurved Mahavidyalaya Kanchanwadi 431011 
Address  OPD Number 13 ,Kayachikitsa Department,CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011
OPD Number 13 ,Kayachikitsa Department,CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011
Aurangabad
MAHARASHTRA
431011
India 
Phone  9422711098  
Fax    
Email  ayushakti009@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Naresh Nimbalkar 
Designation  Associate Professor 
Affiliation  Chatrapati Shahu Maharaj Shikshan sanstha Ayurved Mahavidyalaya Kanchanwadi 431011 
Address  OPD Number13,Kayachikitsa Department,CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011
OPD Number13,Kayachikitsa Department,CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011
Aurangabad
MAHARASHTRA
431011
India 
Phone  9422711098  
Fax    
Email  ayushakti009@gmail.com  
 
Source of Monetary or Material Support  
Dr Kedar Dandare 
 
Primary Sponsor  
Name  Dr Kedar Dandare 
Address  CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar 431011 
Type of Sponsor  Other [SELF sponsered] 
 
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 Kedar Dandare  Chhatrapati Shahu Maharaj Ayurved Mahavidyalay and Hospital  OPD Number 13 Department of Kayachikitsa CSMSS Ayurved Mahavidyalaya Kanchanwadi 431011
Aurangabad
MAHARASHTRA 
8668331644

kedardandare@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CSMSS Ayurveda mahavidayalaya va rugnalaya Kanchanwadi Aurangabad 431011  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Shefali patra kwath, Reference: Bhavprakash Madhyam Khanda Vat vyadhi 26-142, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Rason Saptak Kashay, Reference: Bharat bhaishajyaratnavali 4th part vatvyadhi shloka number 5860, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Eranda Kwath), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -Patients showing Classical Lakshana of Gridhrasi(Sciatica) in working population.
- Patients having positive SLR Test on examination.
- Patients irrespective of both genders will be selected
 
 
ExclusionCriteria 
Details  -The patients suffering from following conditions will be excluded from the study Disease of spine: Like Osteoarthritis Of spine, Spondylolisthesis, Ankylosing spondylitis, Rheumatoid arthritis of hip joint.
- Tuberculosis of vertebral column
 
 
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   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
RUKA (Pain), TODA (Pricking sensation),STAMBHA (Stiffness),SPANDANA (Twitching),Gaurava (Heaviness) will reduce.

 
10th,20th,30th day

 
 
Secondary Outcome  
Outcome  TimePoints 
Straight Leg Raising Test-With the help of Goniometer will asses grades and grade will reduce further treatment  10th,20th,30th day 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   25/10/2024 
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 sign and symptoms of sciatica found in modern medicine are quietly mimic with the condition of  gridhrasi mentioned in ayurveda.vatavyadhi (vata disorder) is one of the most common health issue people suffer from, and almost every person suffers in his lifetimes. “Gridhrasi" is one among the 80 diseases of vata under the nanatmaj vyadhi . Person suffers from grievous pain due which he walks in particular style and so this disease is named as gridhrasi. While walking the patient slightly leans towards the affected side with the affected leg in flexed position and other leg extended   position. Gridhrasi, the name itself indicates the way of Gait shown by the patient due to extreme pain that is "gridha” or vulture.According to charaka acharya, gridhrasi is caused by “aggravated vata” affecting the hip first, which is afflicted by stiffness (stambha), pricking(toda) sensation and pain (ruka) which further radiates towards the waist, back, thigh, knee and calf region in order. These regions constantly have twitching sensation(muhuspanda) .The rasonsaptak Kashaya is advised in bharat bhaishajya ratnavali which is vata and kapha shamak which is used in kwath for which may produce potent and deeper action against gridhrasi. Therefore study is undertaken to evaluate the effect of rasonsaptak kashaya in management of gridhrasi.

 

 
Close