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CTRI Number  CTRI/2024/02/063334 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role of homoeopathic medicine in cases of glaucoma 
Scientific Title of Study   Prospective interventional study to explore the efficacy of homoeopathic medicines in Glaucoma using the Glaucoma quality of life-15 (GQL-15) questionnaire  
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 RAJENDRA PATEL 
Designation  PROFESSOR 
Affiliation  SAT KAIVAL EYE HOSPITAL 
Address  BHARGAVA HOMOEOPATHIC MEDICAL COLLEGE, DAHEMI, TA- BORSAD, DIST- ANAND
OPHTHALMIC OPD DEPARTMENT, ROOM NO 3 & 4, SAT KAIVAL EYE HOSPITAL SARSA
Anand
GUJARAT
388560
India 
Phone  8160360640  
Fax  -  
Email  raju12_1976@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  DR JIGNESH PATEL 
Designation  PROFESSOR 
Affiliation  PARUL UNIVERSITY 
Address  JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, AT POST-LIMDA, WAGHODIA, VADODARA
AT POST-LIMDA, WAGHODIA, VADODARA
Vadodara
GUJARAT
391760
India 
Phone  9909949211  
Fax  -  
Email  jhpatel2003@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR RAJENDRA PATEL 
Designation  PROFESSOR 
Affiliation  SAT KAIVAL EYE HOSPITAL 
Address  BHARGAVA HOMOEOPATHIC MEDICAL COLLEGE, DAHEMI, TA- BORSAD, DIST- ANAND
OPHTHALMIC OPD DEPARTMENT, ROOM NO 3 &4, SAT KAIVAL EYE HOSPITAL SARSA
Anand
GUJARAT
388560
India 
Phone  8160360640  
Fax  -  
Email  raju12_1976@yahoo.co.in  
 
Source of Monetary or Material Support  
SAT KAIVAL EYE HOSPITAL, SARSA 
 
Primary Sponsor  
Name  DR RAJENDRA PATEL 
Address  18, Rajpark Abhilasha, Ganesh Chokdi Anand-388001  
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 RAJENDRA PATEL  SAT KAIVAL EYE HOSPITAL  Ophthalmic OPD Department, Room no 3&4, Sarsa- 388365
Anand
GUJARAT 		 8160360640

raju12_1976@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
EC -SATKAIVAL COLLEGE OF PHARMACY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H400||Glaucoma suspect,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Constitutional medicine mentioned as below Spigelia, Gelsemium, Belladonna etc.  Homoeopathic medicine will be given orally in either 30, 200 or 1M potency two/ three times a day for 3 months 
Comparator Agent  not applicable  Single arm study 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Cases pre-diagnosed or with clinical presentation of Glaucoma will be selected irrespective of age and gender.
 
 
ExclusionCriteria 
Details  Acute congestive glaucoma which require surgical intervention.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the effectiveness of individualized Homoeopathic medicines in the management of Glaucoma
 		 Cases will be evaluated at baseline and at the end of 3 months/12 weeks treatment  
 
Secondary Outcome  
Outcome  TimePoints 
To study the utility of Kent repertory in Glaucoma
 		 1 year 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   01/03/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Glaucoma is very common problem prevalent worldwide as well as in india. It is one of the leading cause for the blindness. Homoeopathic medicines acts well in cases of glaucoma. In order to see the utility of Homoeopathic medicines in glaucoma this study is taken up. 
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