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CTRI Number  CTRI/2025/02/081151 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical study to evaluate the efficacy of Vishwadi Guggulu and Rasna Guggulu with Sahacharadi Taila Matra Basti in treating Sciatica. 
Scientific Title of Study   A randomized comparative clinical study to determine the efficacy of vishwadi guggulu and rasna guggulu along with sahacharadi taila matra basti 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 Joylin Joshina Jathanna 
Designation  PG Scholar 
Affiliation  ALN Rao Memorial Ayurvedic Medical College Koppa Chikmagalur 
Address  Department of Kayachikitsa,1st floor ALN rao memorial ayurvedic medical college Kachkal Road Koppa

Chikmagalur
KARNATAKA
577126
India 
Phone  9448730817  
Fax    
Email  joylinjoshina@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Keshava D V 
Designation  Professor 
Affiliation  ALN Rao Memorial Ayurvedic Medical College Koppa Chikmagalur 
Address  Department of Kayachikitsa,1st floor ALN rao memorial ayurvedic medical college Kachkal Road Koppa

Chikmagalur
KARNATAKA
577126
India 
Phone  9880031849  
Fax    
Email  keshavamdkc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Joylin Joshina Jathanna 
Designation  2nd year Postgraduate 
Affiliation  ALN Rao Memorial Ayurvedic Medical College Koppa Chikmagalur 
Address  Department of Kayachikitsa,1st floor ALN rao memorial ayurvedic medical college Kachkal Road Koppa

Chikmagalur
KARNATAKA
577126
India 
Phone  9448730817  
Fax    
Email  joylinjoshina@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa 1st floor ALN Rao Memorial Ayurvedic Medical College Koppa Chikmagalur Dist 577126 Karnataka India 
 
Primary Sponsor  
Name  Dr Joylin Joshina Jathanna 
Address  Department of Kayachikitsa 1st floor ALN Rao Memorial Ayurvedic Medical college and PG Center Koppa Chikmagalur District 577126 Karnataka India  
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 Joylin Joshina Jathanna  ALN Rao Memorial Ayurvedic Medical College Hospital  Kayachikitsa OPD Room no 1, ALN Rao Memorial Ayurvedic Medical College Hospital Koppa 577126
Chikmagalur
KARNATAKA 		 9448730817

joylinjoshina@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ALN Rao Memorial Ayurvedic Medical College Koppa Chikmagalur Karnataka  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charaka Samhitha, Procedure details: Sahacharadi Taila 30 ml given as Matra Basti for 15 days)
(1) Medicine Name: Gandharvahastadi taila, Reference: Astanga Sangraha, Route: Oral, Dosage Form: Capsules, Dose: 750(mg), Frequency: od, Duration: 1 Days
(2) Medicine Name: Rasna guggulu, Reference: Chakradatta, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: tds, Duration: 30 Days
2Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: charaka samhita, Procedure details: sahacharadi taila 30 ml given as matra basti for 15 days)
(1) Medicine Name: vishwadi guggulu, Reference: brihat nighantu ratnakra, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: tds, Duration: 30 Days
(2) Medicine Name: gandharva hastadi taila, Reference: ashtanga sangraha, Route: Oral, Dosage Form: Capsules, Dose: 750(mg), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects of either sex
2.Subjects within the age group of 20 to 60 years
3. Subjects with clinical features of Gridhrasi such as ruk, toda, stambha, spandana which starts from sphik pradesha and radiating towards foot along with aruchi, tandra and gourava will be included
4.Chronicity less than 5 Years
5.Subjects with controlled systemic disorder such as Diabetes mellitus, Hypertension etc
6.Subjects must be capable of giving informed consent, willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures. 
 
ExclusionCriteria 
Details  1. Pregnant and Lactating women
2. Subjects with diagnosed uncontrolled systemic disorder such as Diabetes mellitus, Hypertension, etc.
3. Gridhrasi due to any post-surgical
complication,infective and degenerative conditions of spine. (Complications of cauda equina syndrome)
4.Patients who have lost the bowel and bladder control.
5.Patients with H/O acute traumatic injury.
(Complications of cauda equina syndrome) 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Ruk/Pain
Toda/Pricking pain
Stambha/Stiffness
Spandana/Pulsating
Aruchi/loss of taste
Tandra/Drowsy
Gourava/Heaviness 		 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   04/03/2025 
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="3"
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   It is a clinical study to evaluate the effectiveness of rasna guggulu and vishwadi guggulu with sahacharadi taila matra basti given in the patients of gridhrasi.Total 60 number of patients divided into 2 groups and administered with above drugs, internal medication for 30 days and matra basti for 15 days. Assessment parameters like ruk, toda, sthambha, spandana, aruchi, tandra, gourava as subjective parameters and SLR, bregards sign, 50 feet walk test as objective parameters are observed on 0th, 15th, 30th, 60th day at Kayachikitsa OPD, ALN rao memorial ayurvedic hospital. 
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