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CTRI Number  CTRI/2024/04/065145 [Registered on: 03/04/2024] Trial Registered Prospectively
Last Modified On: 23/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Management of eye complaints related to Computer Vision Syndrome using Complete Repertory.  
Scientific Title of Study   A non-randomized clinical study to assess the role of complete repertory in the management of ocular complaints of Computer Vision Syndrome using CVS-Q scale  
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 Shaikh Mohammed Baberali  
Designation  MD (PG scholar)  
Affiliation  Bharati vidyapeeth (deemed to be university) Homoeopathic Medical College and Homoeopathic Hospital 
Address  Bharati vidyapeeth (deemed to be university) Homoeopathic Medical College and Homoeopathic Hospital, Dept of Post Graduate and Research centre, Pune-Banglore Highway, Pune.

Pune
MAHARASHTRA
411043
India 
Phone  8888760963  
Fax    
Email  mohammedshaikh1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajendra Eknath Shinde 
Designation  Associate Professor 
Affiliation  Bharati vidyapeeth (deemed to be university) Homoeopathic Medical College and Homoeopathic Hospital 
Address  Bharati vidyapeeth (deemed to be university) Homoeopathic Medical College and Homoeopathic Hospital, Dept of Post Graduate and Research centre, Pune-Banglore Highway, Pune.

Pune
MAHARASHTRA
411043
India 
Phone  9637206722  
Fax    
Email  rajendra.shinde@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Shaikh Mohammed Baberali  
Designation  MD (PG scholar)  
Affiliation  Bharati vidyapeeth (deemed to be university) Homoeopathic Medical College and Homoeopathic Hospital 
Address  Bharati vidyapeeth (deemed to be university) Homoeopathic Medical College and Homoeopathic Hospital, Dept of Post Graduate and Research centre, Pune-Banglore Highway, Pune.

Pune
MAHARASHTRA
411043
India 
Phone  8888760963  
Fax    
Email  mohammedshaikh1997@gmail.com  
 
Source of Monetary or Material Support  
B.V.D.U.Homoeopathic Medical College and Hospital,Dept of Post Graduate and Research Centre.  
 
Primary Sponsor  
Name  Dr Shaikh Mohammed Baberali 
Address  Bharatividyapeeth (deemed to be university) Homoeopathic Medical College and Homoeopathic Hospital ,Dept of Post Graduate and Research centre , Pune-Banglore Highway ,Pune-411043  
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 Shaikh Mohammed Baberali  BVDU Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research center.  3rd floor, Department of Repertory,Dept of Post Graduate and Research centre, Bharati vidyapeeth (deemed to be university) Homoeopathic Hospital, ,Pune-Banglore Highway ,Pune-411043
Pune
MAHARASHTRA 		 8888760963

mohammedshaikh1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Bharati Vidyapeeth (DTU) HMC, Pune.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicine obtained after repertorization by complete repertory.  Homoeopathic medicine will be prescribed at the beginning of the study and at every follow up ( with duration of every 7th day for 5 weeks).Potentised homoeopathic medicine will be used in the form of pills or powder. Route of administration: Oral Selection of potency: The drug will administered in various potencies(30,200,1M etc) as per the need of patient. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1) Cases presenting with ocular complaints of computer vision syndrome with CVS-Q scale score above or equal to 6, in age group between 18-45 years irrespective of sex will be included in the study.2) Those who are willing to participate and give consent. 
 
ExclusionCriteria 
Details  1) Patient pre diagnosed with any error of refraction will be excluded. 2) Cases complicated with acute, chronic, infective conjunctivitis, any specific eyelid disorders, corneal ulcers, dacryocystitis, keratoconjunctivitis sicca, lagophthalmos, Sjogren’s syndrome, ocular diseases like cataract and history of eye surgery will be excluded. 3) Patient using any kind of eye drops, UV protection spectacles and contact lenses will be excluded. 4) Patients who may not be able to come for regular follow up will be excluded.
5) Patients suffering from any systemic or metabolic disorders and on medication will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study and prescribe homoeopathic medicine for ocular complaints of computer vision syndrome using complete repertory as a tool of study.  To study and prescribe homoeopathic medicine for ocular complaints of computer vision syndrome using complete repertory as a tool of study.Follow up of case will be done on every 7th day after starting the treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the efficacy of homoeopathic medicines by using complete repertory in the management of ocular complaints of computer vision
syndrome. 		 The follow up taken for one and half month ( on every 7th day for subsequent 5 weeks ) will be used to assess efficacy of Homoeopathic medicines by using complete repertorty in the management of ocular complaints of computer vision syndrome by using CVS-Q Scale before and after the treatment. 
 
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 3 
Date of First Enrollment (India)   15/04/2024 
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="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   This study is non-randomized, single armed trial to study and prescribe homoeopathic medicine in the management of ocular complaints of Computer Vision Syndrome using Complete Repertory as tool of study.
The duration of the treatment is one and half month and will be done on 30 patients at BVDUHMC, PUNE. The follow up of the case will be done on 7th day after starting the treatment, and subsequent follow ups will be scheduled every week for 5 weeks,  all the cases will be repertorized by Complete Repertory.
After proper case taking of the patients with consideration of ocular complaints of computer vision syndrome, will be given proper indicated Homoeopathic medicine, and will be assessed by CVS-Q scale before and after the treatment.
 
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