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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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. |