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CTRI Number  CTRI/2025/08/093917 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Vrishadi Niruha Kala Basti in Gridhrasi (Sciatica) 
Scientific Title of Study   Clinical evaluation of Vrishadi Niruha Kala Basti in 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  Ranjana Nautiyal 
Designation  Pg Scholar 
Affiliation  Himalayiya Ayurvedic Pg Medical College and Hospital  
Address  Opd No. 11 Department of Panchakarma Himalayiya Ayurvedic Pg Medical College and Hospital Fatehpur Tanda Majri Grant via Doiwala Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  8279354482  
Fax    
Email  ranjunautiyal123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arvind Gupta 
Designation  Professor 
Affiliation  Himalayiya Ayurvedic Pg Medical College and Hospital  
Address  Opd No 11 Department of Panchakarma Himalayiya Ayurvedic Pg Medical College and Hospital Fatehpur Tanda Majri Grant Via Doiwala Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  7895624474  
Fax    
Email  arvindguptapk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arvind Gupta 
Designation  Professor 
Affiliation  Himalayiya Ayurvedic Pg Medical College and Hospital  
Address  Opd No. 11 Department of Panchakarma Himalayiya Ayurvedic Pg Medical College and Hospital Fatehpur Tanda Majri Grant via Doiwala Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  7895624474  
Fax    
Email  arvindguptapk@gmail.com  
 
Source of Monetary or Material Support  
Department of Panchakarma Himalayiya Ayurvedic Pg Medical College and Hospital Fatehpur Tanda Majri Grant Via Doiwala Dehradun 248140 
 
Primary Sponsor  
Name  Dr Ranjana Nautiyal 
Address  Opd No 11 Department of Panchakarma Himalayiya Ayurvedic Pg Medical College and Hospital Fatehpur Tanda Majri Grant Via Doiwala Dehradun 248140 
Type of Sponsor  Other [SELF] 
 
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 Ranjana Nautiyal  Himalayiya Ayurvedic Pg Medical College and Hospital  Opd no 11 Department of Panchakarma Himalayiya Ayurvedic Pg Medical College and Hospital Fatehpur Tanda Majri Grant Via Doiwala Dehradun
Dehradun
UTTARANCHAL 		 8279354482

ranjunautiyal123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Minutes Of Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: sushruta samhita Chikitsa sthan 38/67-70, Procedure details: Deepana pachana- Chitrakadi vati 2tab. BD Sthanika abhyanga and swedana- Murchita tila tail and Dashmool kwath Anuvasana Basti- Vrishadi Tail (130ml) Niruha Basti- Vrishadi Kwath (520ml))
(1) Medicine Name: Vrishadi asthapana, Reference: sushruta samhita Chikitsa sthan 38/67-70, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 520(ml), Frequency: od, Duration: 6 Days
(2) Medicine Name: Vrishadi anuvasana, Reference: sushruta samhita Chikitsa sthan 38/67-70 , Route: Rectal, Dosage Form: Taila, Dose: 130(ml), Frequency: od, Duration: 10 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Presence of the classical sign and symptoms of Gridhrasi (Sciatica).
Patients fit for Basti procedure.
Patient with tenderness along the course of sciatic nerve.
 
 
ExclusionCriteria 
Details  Patients unfit for Basti procedure.
Patients with Uncontrolled Diabetes mellitus, Renal disorder, Cardiovascular disease.
Pregnant and lactating mother.
Diagnosed cases of Pott’s Spine and Lumbosacral malignancy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reducing pain, Symptoms relief (Toda, Stambha, Spandana, Tandra, Gaurava, Aruchi), Improving functional ability  3 wks 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in SLR angle, increase walking time   7 wks 
 
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 2/ Phase 3 
Date of First Enrollment (India)   08/09/2025 
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="1"
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   Gridhrasi is the most complex and prominent disease among 80 types of Nanatmaja vata vyadhis. It is characterised by radiating pain from the Lumbosacral region through the thigh, knee, calf and foot. the cardinal sign and symptoms of Gridhrasi are Ruka, Toda, Stambha, Spandana. In kaphanubandha Gridhrasi Tandra, Gaurav, Aruchi are also present.
In Sushruta Samhita VRISHADI NIRUHA BASTI is indicated in the management of Gridhrasi. In present study Kala Basti schedule is selected. 30 patients who were suffering from Gridhrasi and who fulfilling the diagnostic and inclusion criteria will be selected for the clinical study so here is an attempt to evaluate the efficacy of Basti in Gridhrasi under the topic "CLINICAL EVALUATION OF VRISHADI NIRUHA KALA BASTI IN GRIDHRASI (SCIATICA)"
 
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