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CTRI Number  CTRI/2025/04/085932 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On: 22/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Use OF VISHTINDUKA TAILA & VATARI GUGGULU IN GRIDHRASI (SCIATICA)  
Scientific Title of Study   AN EXPERIMENTAL DERMAL SAFETY STUDY OF SCHEDULE E (1) DRUG - VISHTINDUKA AND THE ROLE OF ITS TAILA & VATARI GUGGULU IN GRIDHRASI  
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 Rupali Yadav 
Designation  PG Scholar 
Affiliation  Shri NPA Govt. Ayurvedic College G.E. road Raipur 492010 
Address  Department of Agadtantra Evum Vidhi Ayurved Shri NPA Govt. Ayurvedic College G.E. road Raipur 492010

Raipur
CHHATTISGARH
492010
India 
Phone  7974149684  
Fax    
Email  rupaliyadavbsp1995@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangeeta Bhagat 
Designation  Reader of Agad tantra Evum Vidhi Ayurved  
Affiliation  Shri NPA Govt. Ayurvedic College G.E. road Raipur 492010 
Address  Department of Agad Tantra Evum Vidhi Ayurved Shri NPA Govt. Ayurvedic College G.E. road Raipur 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9691313898  
Fax    
Email  babybhagat13@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ranjip Kumar Dass 
Designation  Professor & HOD of Panchakarma 
Affiliation  Shri NPA Govt. Ayurvedic College G.E. road Raipur 492010 
Address  Department of Panchakarma Shri NPA Govt. Ayurvedic College G.E. road Raipur 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9017418807  
Fax    
Email  drranjipayu@yahoo.co.in  
 
Source of Monetary or Material Support  
Shri Khudadad Dungaji Govt. Ayurvedic Hospital Raipur Chhattisgarh 492010 
 
Primary Sponsor  
Name  Department of Agadtantra Evum Vidhi Ayurved Shri NPA Govt Ayurvedic College GE road Raipur  
Address  Department of Agadtantra Evum Vidhi Ayurved Shri NPA Govt. Ayurvedic College G.E. road Raipur 492010 
Type of Sponsor  Government 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 Rupali Yadav  Shri Khudadad Dungaji Govt. Ayurvedic Hospital Raipur Chhattisgarh 492010  OPD no 9 Department of Panchakarma Shri Khudadad Dunga ji Govt. Ayurvedic Hospital Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH 
7974149684

rupaliyadavbsp1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Govt Ayurved College Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vishtinduka Taila, Reference: Ras Tarangini, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Vatari Guggulu, Reference: Bhaishajay Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -chew guggulu properly
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patient between the age of 18-60 years randomly included in study
2 Sex – both male and female
3 Duration of illness – upto 1 year
4 Tenderness of the Sciatic Nerve course
5 Severe pain on squatting
6 Radiating pain, starting from the gluteal region towards the foot
7 Sensory change
8 Non-involvement of Urinary Bladder and Rectum
9 Positive straight leg raising sign

 
 
ExclusionCriteria 
Details  1 Age below 20 years and above 70 years
2 Duration of disease more than 1 years
3 Monoplegia
4 Paraplegia
5 Hip joint arthritis
6 TB Spine/Hip
7 Pelvic pathology
8 Traumatic lesion in lumbo – sacral region

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Subjective parameter
1 Stambha
2 Ruka
3 Toda
4 Muhurmuhu spandanam
5 Sakthikshepana nigrahat
6 Dehasya pravakrata
7 Tandra
8 Gaurava
9 Aruchi
10 Vahnimardavam (Agnimandhya)
11 Mukhapraseka
12 Bhaktadwesh
13 Staimitya
OBJECTIVE PARAMETERS –
1 Lasegue’s test
2 Bragard’s test
3 Bowstring’s test
4 Sitting time
5 Standing time
6 Walking distance
 
30 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Effectiveness of Vishatinduka Taila & Vatari Guggulu in reducing pain associated with sciatica. Improvements in patient’s quality of life due to reduced pain & increased mobility would be an important outcome  30 Days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3/ Phase 4 
Date of First Enrollment (India)   17/08/2025 
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="0"
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  

Ayurveda, an ancient science of life, focuses on maintaining balance for health and longevity. It divides health principles into eight branches, one of which is Agad Tantra, dealing with poisons and their treatment. Acharya Charak emphasized that poisons, when properly prepared, can become medicines, and conversely, even beneficial medicines can become toxic if used incorrectly. A key part of Ayurveda is understanding Tridosha—the balance of Vata, Pitta, and Kapha. When these energies are in equilibrium, health prevails; imbalances lead to diseases.

One such disease is Gridhrasi, similar to sciatica in modern medicine, characterized by pain, stiffness, and restricted leg movement. It arises from imbalances in Vata, and in some cases, also Kapha. Sciatica is a common condition, caused by issues like poor posture, prolonged sitting, and obesity. It affects many individuals, especially those aged 30-50, and often leads to pain, disability, and discomfort.

In Ayurveda, treatments such as Vishtinduka Taila (derived from Strychnos nux-vomica, a poisonous plant) and Vatari Guggulu (a herbal remedy) are used for conditions like Gridhrasi. These treatments have properties like pain relief, anti-inflammatory, and nerve tonic effects. However, the toxic potential of these treatments, especially from the use of Vishtinduka, requires careful evaluation. Toxicity studies in animals are essential to ensure their safety for human use.

This study aims to evaluate the safety of Vishtinduka Taila through dermal exposure in rats and its clinical effectiveness in treating Gridhrasi. Additionally, Vatari Guggulu’s non-toxic profile has already been established. The ultimate goal is to find an effective, safe treatment for sciatica, using traditional Ayurvedic remedies.

 
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