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CTRI Number  CTRI/2022/09/046037 [Registered on: 29/09/2022] Trial Registered Prospectively
Last Modified On: 28/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Bhadradarvadi Kashayam and Medicated Oil Enema (matra basti) with Brihat Saindhavadi Taila in low back pain (Sciatica) 
Scientific Title of Study   A Clinical Study on the Combined Effect of Bhadradarvadi Kashayam and Brihat Saindhavadi Taila Matra Basti in the Management of Gridrasi with reference to 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 Shilpa Sasikumar 
Designation  Postgraduate scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Department of Kayachikitsa Room No 17 first floor Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9790900288  
Fax    
Email  13201a005@sjsach.org.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep Kumar Moharana  
Designation  Professor 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Department of Kayachikitsa Room No 17 first floor Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9444123608  
Fax    
Email  pkm_ayur@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shilpa Sasikumar 
Designation  Postgraduate scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Department of Kayachikitsa Room No 17 first floor Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9790900288  
Fax    
Email  13201a005@sjsach.org.in  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda College and Hospital  
 
Primary Sponsor  
Name  Dr Shilpa Sasikumar 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Department of Kayachikitsa Room No 17 first floor Nazarathpet Chennai Thiruvallur TAMIL NADU 600123 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 Shilpa Sasikumar  Sri Jayendra Saraswathi Ayurveda College and Hospital  Sri Jayendra Saraswathi Ayurveda College and Hospital Department of Kayachikitsa Room No 17 first floor Nazarathpet Chennai Thiruvallur TAMIL NADU 600123 India
Thiruvallur
TAMIL NADU 		 9790900288

13201a005@sjsach.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics 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 ArmDrugClassical(1) Medicine Name: Bhadradarvadi kashayam , Reference: Ashtanga hridayam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charaka Samhita, Procedure details: Administration of matra Basti with Brihat saindhavadi taila for 14 days.)
(1) Medicine Name: Brihat saindhavadi taila, Reference: Bhaishajya Ratnavali, Route: Rectal, Dosage Form: Taila, Dose: 70(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients with pratyatmak lakshana of gridrasi i.e., ruk, toda, stabda, spandana in the sphik, kati, uru, janu, jangha, and pada
2. Patients who had fall or direct trauma
 
 
ExclusionCriteria 
Details  1. Deformities and congenital defects of the spine
2. Fracture of the vertebra
3. Systemic disorders like diabetes, hypertension
4. Malignancy
5. Pregnant and lactating women
6. Ankylosing spondylitis
7. Infective conditions like osteomyelitis, tuberculosis
8. Piriformis syndrome
9. Anal pathologies like hemorrhoids, anal fissure, anal abscess, perianal warts, anal fistula, rectal prolapse, and anal/rectal carcinoma
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the patients using these parameters
Visual Analogue Scale
Pain assessment by Roland-Morris low back pain and disability questionnaire
Functional disability- Oswestry Disability Index
 		 Criteria will be assessed on day 15 
 
Secondary Outcome  
Outcome  TimePoints 
To assess
Visual Analogue Scale
Pain assessment by Roland-Morris low back pain and disability questionnaire
Functional disability- Oswestry Disability Index 		 Criteria will be assessed on follow up day 31 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 
Date of First Enrollment (India)   14/10/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In the present day-to-day lifestyle, improper sitting posture, continuous and overexertion, and jerky movements during traveling by automobile vehicles and sports activities create undue pressure over lumbosacral area because of the anatomic lordotic curvature. Sciatica refers to the pain that radiates along the path of the sciatic nerve. The cardinal signs and symptoms of gridrasi are pain, pricking sensation, stiffness, and twitching in the gluteal region, waist, low back, thigh, knee, calf, and foot. Anorexia, stupor, and heaviness may be associated. Gridrasi being a shula pradhana vatavyadhi Bhadradarvadi kashayam is prescribed for its vatahara property. Brihat saindhavadi taila is having vatahara property, reduces pain in kati, janu and uru pradesha. In vata vyadhi snehanam is the first line of treatment mentioned according to Acharya Charaka. Basti is the best treatment modality adopted to pacify vata dosa. Matra basti can be practiced without strict regimental stipulations and it is effective in eliminating mala easily, bringing back the dosas to normalcy. It not alone corrects the vata disorders but also equally effective in correcting the morbid pitta, kapha, and rakta. A humble attempt is done here to study the effect of Bhadradarvadi kashayam and Brihat Saindhavadi taila matra basti in the management of gridrasi (sciatica). 
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