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CTRI Number  CTRI/2024/04/065536 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 21/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A Study to Understand the Usefulness of Cotyledon umbilicus in reducing the pain of sciatica prescribed according to the symptoms given in The Encyclopedia of Pure Materia Medica 
Scientific Title of Study   Open Label Prospective Clinical Study to Assess the Efficacy of Cotyledon umbilicus Prescribed According to “The Encyclopedia of Pure Materia Medica” for Managing the Pain of 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  Dr Shayantan Kumar Das 
Designation  PG Scholar 
Affiliation  Dr MPK Homoeopathic Medical College Hospital and Research Centre 
Address  Department Of Materia Medica Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Plot no 10,11,12 Saipura Sanganer Jaipur

Jaipur
RAJASTHAN
302029
India 
Phone  9163680740  
Fax    
Email  shayantandas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vanija Sharma 
Designation  Associate Professor and Head of the Department of Materia Medica 
Affiliation  Dr MPK Homoeopathic Medical College Hospital and Research Centre 
Address  Department Of Materia Medica Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Plot no 10,11,12 Saipura Sanganer Jaipur

Jaipur
RAJASTHAN
302029
India 
Phone  9680438770  
Fax    
Email  drvanijasharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shayantan Kumar Das 
Designation  PG Scholar 
Affiliation  Dr MPK Homoeopathic Medical College Hospital and Research Centre 
Address  Department Of Materia Medica Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Plot no 10,11,12 Saipura Sanganer Jaipur

Jaipur
RAJASTHAN
302029
India 
Phone  9163680740  
Fax    
Email  shayantandas@gmail.com  
 
Source of Monetary or Material Support  
Department Of Materia Medica Dr Girendra Pal Homoeopathic Hospital and Research Centre A Collegiate Hospital of Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur 302029 
 
Primary Sponsor  
Name  Dr MPK Homoeopathic Medical College, Hospital and Research Centre 
Address  Plot no 10,11,12 Saipura Sanganer Jaipur Pincode 302029 
Type of Sponsor  Private 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 Shayantan Kumar Das  Dr Girendra Pal Homoeopathic Hospital and Research Centre  Department of Materia Medica, Room no 4, Unit 1, Dr MPK Homoeopathic Medical College, Hospital and Research Centre, Homoeopathy University, Plot no 10,11,12 Saipura Sanganer Jaipur Pincode 302029
Jaipur
RAJASTHAN 		 9163680740

shayantandas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Homoeopathy University Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M543||Sciatica,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cotyledon umbilicus  Oral administration of Cotyledon umbilicus in 30C two globules of size 40, dose and repetition - TDS and will be followed after 15 days or as per need of the case. Higher potency 200C and 1M of Cotyledon umbilicus will be given orally in form of globules size 40, dose and repetition – one dose followed by placebo two globules TDS for 15 days or as per need of the case. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patient giving consent for the study.
2.Patient having minimum 3 symptoms of the following of Cotyledon umbilicus mentioned in “The Encyclopedia of Pure Materia Medica” by T. F. Allen as follows:
✓ Aching bruised pain all over the lower limbs. She can scarcely walk for aching in the limbs, legs feel heavy and sore.
✓ Pain and stiffness of the right hip, going off after a walk, in the evening. Shooting pain, sudden and sharp, in the right infra gluteal region, felt principally on walking in the open air.
✓ Great aching of the hip joint, relieved by moving about. Continual soreness of the hip and thigh, posteriorly.
✓ Aching in the left thigh, posteriorly. Aching in the back part of the left thigh, with numbness. Stringing pain under the left gluteal maximus, in the region of great sciatic nerve
3.Diagnosed cases taking treatment from other system of medicine having no relief seeking homoeopathic treatment.
4.Undiagnosed cases will be enrolled after confirming the following criteria: -
✓ Straight Leg Raise (SLR) positive.
✓ Patient presenting with clinical features of pain radiating down the back to the extremities with positive result of one or more neurological examination indicating nerve root tension or neurological deficit and numbness of the limbs.
✓ Xray of Lumbosacral Region (PA and Lateral View). 
 
ExclusionCriteria 
Details  1.Females those are pregnant or lactating.
2.Patient refusing or not willing to give consent for the study.
3.Patient suffering from severe systemic diseases.
4.Cases requiring emergency/surgical intervention.
5.Patient from other pharmacological intervention and are not willing to leave it.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement of the score obtained (pre and post treatment) from Modified Roland Morris Disability scale.  Pre score will be taken at the baseline of treatment and post scores will be assessed at the end of 3 months using Modified Roland Morris Disability Scale. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of Cotyledon umbilicus in alleviating pain of sciatica prescribed according to the symptoms mentioned in "The Encyclopedia of Pure Materia Medica" and enlist additional symptoms verified during the study.  12 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   22/04/2024 
Date of Study Completion (India) 21/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   This study is a prospective, non-randomized, open-label, single arm, unicentric, interventional clinical study to assess the efficacy of Cotyledon umbilicus in alleviating the pain of sciatica prescribed according to the symptoms mentioned in "The Encyclopedia of Pure Materia Medica". The study will evaluate the extend of improvement in pain due to sciatica using Modified Roland Morris Disability Scale as an assessment scale and to enlist additional symptoms verified during the study. The primary outcome will be according to the scores obtained (pre and post treatment) from the Modified Roland Morris Disability Scale. The secondary outcome will be assessing the efficacy of Cotyledon umbilicus in alleviating the pain of sciatica according to the symptoms mentioned in The Encyclopedia of Pure Materia Medica and enlisting additional symptoms verified during the study. 
NULL HYPOTHESIS (H0) – There will be no significant improvement in pain in the cases of sciatica after prescribing Cotyledon umbilicus based on symptoms mentioned in “The Encyclopedia of Pure Materia Medica” by T. F. Allen.
ALTERNATIVE HYPOTHESIS (H1) – There will be significant improvement in pain in the cases of sciatica after prescribing Cotyledon umbilicus based on symptoms mentioned in “The Encyclopedia of Pure Materia Medica” by T. F. Allen.
 
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