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CTRI Number  CTRI/2019/12/022290 [Registered on: 10/12/2019] Trial Registered Prospectively
Last Modified On: 07/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   AYURVEDIC MANAGEMENT OF GRIDHRASI (SCIATICA) WITH RASONA KSHIRAPAKA  
Scientific Title of Study   A CLINICAL EVALUATION OF RASONA KSHIRAPAKA IN THE MANAGEMENT OF GRIDHRASI(SCIATICA) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR VIDHIBEN P PATEL 
Designation  PG SCHOLAR 
Affiliation  J S AYURVEDA MAHAVIDYALAYA 
Address  J S AYURVEDA MAHAVIDYALAYA COLLEGE ROAD NADIAD

Kheda
GUJARAT
387001
India 
Phone  9429624828  
Fax    
Email  vidhi.patel257@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR DHAVAL DHOLAKIYA 
Designation  READER 
Affiliation  J S AYURVEDA MAHAVIDYALAYA 
Address  J S AYURVEDA MAHAVIDYALAYA COLLEGE ROAD NADIAD

Kheda
GUJARAT
387001
India 
Phone  7016786089  
Fax    
Email  vddhavaldholakiya1910@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR VIDHIBEN P PATEL 
Designation  PG SCHOLAR 
Affiliation  J S AYURVEDA MAHAVIDYALAYA NADIAD 
Address  J S AYURVEDA MAHAVIDYALAYA COLLEGE ROAD NADIAD

Kheda
GUJARAT
387001
India 
Phone  9429624828  
Fax    
Email  vidhi.patel257@gmail.com  
 
Source of Monetary or Material Support  
SUNDAR AYURVEDA PHARMACY 
 
Primary Sponsor  
Name  J S AYURVEDA MAHAVIDYALAYA 
Address  J S AYURVEDA MAHAVIDYALAYA COLLEGE ROAD NADIAD 387001 
Type of Sponsor  Private medical college 
 
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 VIDHIBEN P PATEL  P D PATEL AYURVEDA HOSPITAL  kayachikitsa and panchakarma OPD
Kheda
GUJARAT 		 9429624828

vidhi.patel257@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTE FOR HUMAN RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G570||Lesion of sciatic nerve,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1 rasona kshirapaka 2 placebo tablets  1. rasona kshirapaka made with classical referance 12.5 gm of rasona(allium sativum),100ml Milk, 100ml water 2. placebo tablets made with wheat flour given along with rasona kshirapaka 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  (1) Presence of Ruk, Toda, Stambha and Spandana in the Sphik, Kati, Uru, Janu, Jangha and Pada.
(2) Sakthiksepadautkshepada Nigraha (S.L.R. test) in affected leg as objective measure for diagnosis as well as for improvement of the treatment.
(3) Patients between the ages of 18 – 60 years. 
 
ExclusionCriteria 
Details  (1) Pregnant/lactating woman
(2) Patients suffering from pathological condition like bone tumor, spine tuberculosis, scoliosis, kyphosis etc.
(3) Patients having HbA1c >7.5 of diabetes mellitus.
(4) Patients who have taken medication of corticosteroids, psycho pharmacological drugs within last 2 months.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
EFFECT OF AYURVEDIC MANAGEMENT IN THE PATIENTS OF SCIATICA  AFTER ALL PATIENTS WILL ENROLLED AND TREATMENT WILL COMPLETED THE DATA WILL BE ASSESSED 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "23"
Final Enrollment numbers achieved (India)="23" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/12/2019 
Date of Study Completion (India) 23/07/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NOT APPLICABLE. THIS THESIS WORK WILL YET TO BE SUBMIT. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Study shows that the females in the age group of 40-60 years are the main sufferers. The analysis of the ātura bala revealed that maximum patients (73.91%) had madhyama level of viniścita bala. Observation shows vāta factor in prakṛti as an etiological contributor. Parihāṇi kāla (a degenerative phase) is also a factor in causation of the disease. Majority (60.86%) of the patients suffered from vāta-kaphaja type gṛdhrasī, and 30.13% from vātaja gṛdhrasī, which may be due to modern life style which favors vāta-kapha factors. In maximum patient of gṛdhrasī, vāyu is aggravated due to mārgāvarodha. In the study, involvement of kaṇḍarā- śirā-snāyu as dūśya was found in all patients i.e. 100% of patients, and involvement of māṁsa and asthi was found in 91.30% and 86.95% patients respectively.

As an overall effect of the treatment 14 patients had marked response whereas 5 patients moderately responded. 1 patient had mild response. 3 patients were drop out among them 1 patient was drop out because of irregular follow up due to family problem and 2 patients drop out reason were unknown. None of the patients developed any untoward symptoms or any side effects during the course of the treatment and therefore these medicines in this therapeutic dosage are safe.

 

The ultimate effect was achieved in the patients of gṛdhrasī by the reduction of pain and controlling the vitiated vāta-kapha dośa. Along with that, bṛmhaṇa and rasāyana effects of kṣīrapāka kalpana should also be accomplished as a part of treatment of vātavyādhi. Present study reveals that the selected management has potential effect on gṛdhrasī. Significant improvement was observed in all the symptoms as well as on SLR.


 
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