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CTRI Number  CTRI/2020/02/023536 [Registered on: 24/02/2020] Trial Registered Prospectively
Last Modified On: 19/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic management of senile immature cataract 
Scientific Title of Study   Effectiveness Of Ayurvedic Treatment for Kaphaja Kacha in Senile Immature Cataract 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Adarsh P S 
Designation  PG Scholar 
Affiliation  Amrita School of Ayurveda 
Address  Department of Salakyatantra Amrita School of Ayurveda Clappana P O Kollam Kerala

Kollam
KERALA
690525
India 
Phone  9061195295  
Fax    
Email  psadarsh1993@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashwini B N 
Designation  Associate Professor 
Affiliation  Amrita School of Ayurveda 
Address  Department of Salakyatantra Amrita School of Ayurveda Clappana P O Kollam Kerala

Kollam
KERALA
690525
India 
Phone  7025867095  
Fax    
Email  drashwinibelludi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashwini B N 
Designation  Associate Professor 
Affiliation  Amrita School of Ayurveda 
Address  Department of Salakyatantra Amrita School of Ayurveda Clappana P O Kollam Kerala

Kollam
KERALA
690525
India 
Phone  7025867095  
Fax    
Email  drashwinibelludi@gmail.com  
 
Source of Monetary or Material Support  
Amrita School of Ayurveda Amritapuri Clappana P O Kollam 
 
Primary Sponsor  
Name  Amrita School of Ayurveda 
Address  Amrita School of Ayurveda Clappana P O Kollam Kerala 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Adarsh P S  Amrita School of Ayurveda  Department of Salakyatantra Amrita School of Ayurveda Clappana P O Kollam Kerala
Kollam
KERALA 
9061195295

psadarsh1993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Amrita Institute of Medical Sciences and Research Centre Kochi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H259||Unspecified age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Pachana deepana Snehapana Abhyanga and bashpasweda Virechana Marsha nasya Anjana  Before starting Snehapana Pachana deepana with Vaiswanara choornam 6gm along with hot water twice daily after food is given to enhance agni for the first 2 days then Snehapana with Triphala gritha 30 to 150 ml depending on agni is given in the early morning for the next 5 days Hot water is to be taken sip by sip after taking the ghee After Snehapana for 5 days Asanavilwadi Taila is given for anointing the body prior to hot water bath 2days Next day Virechanam is done with Trivrut lehya 15 to 50gm to based on koshta which is mentioned in kaphaja timira chikitsa From the next day onwards Nasya with Anutaila will be done for the next 5 days and Vimala Varthi Anjana will be done for the last 30 days Also Triphala choornam with half tsp Gogrita Ghee and 1 tsp Madhu Honey at night after food will be administered internally during the treatment course 30days 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients aged 50 to 70 years
Patients with senile immature cataract in one or both eyes
Patient with Visual acuity 6 by 9 or less in Snellens Chart
Patient fit for Anjana and Nasya 
 
ExclusionCriteria 
Details  Patients with Senile Mature cataract or Hypermature cataract in both eyes
Any other ocular pathologies causing blurring of vision
Patients under any kind of Immuno suppressant drugs
Patients with Visual acuity of 6 by 60 and less 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Blurring of Distant vision
Blurring of Near vision
Halos
Diplopia
 
1st day
75th day
105th day
135th day 
 
Secondary Outcome  
Outcome  TimePoints 
LOCS 3 Grading  1st day
75th day
105th day
135th day 
 
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 3/ Phase 4 
Date of First Enrollment (India)   01/03/2020 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Cataract is the most common cause of vision loss in people over age 45 and is the principal cause of blindness in the world. In India there are 12 million blind people and 80.1% of these are blind due to cataract. The annual incidence of cataract blindness is about 3.8 million. ‘Age-related cataract’ also called as senile cataract is the commonest type of acquired cataract affecting equally persons of either sex usually above the age of 50 years. The condition is usually bilateral, but one eye is affected earlier than the other. Senile cataract is the most important cause of avoidable blindness. Till date an effective medical therapy for senile cataract has not been found out. The only treatment of choice is surgery.

Considering the signs and symptoms, senile immature cataract can be compared with kaphaja kacha in Ayurveda. In kaphaja kacha stage, person sees objects as though covered with white cloth, drishti turns white in colour, along with the symptoms of blurring of vision enumerated in the early stages of the timira. Ayurveda treatment for Kaphaja Timira and Kacha includes Snehapanam, Virechanam, Nasyam & Anjanam.

The study will be a single group of pre and post-test study on 60 eyes with signs and symptoms of Senile Immature Cataract who fulfil diagnostic and inclusion criteria belonging to either sex will be selected will be selected from the OPD & IPD of Salakyatantra department of Amrita School of Ayurveda. Before treatment the subjective & objective parameters will be assessed & recorded in a case record form.

Before starting Snehapana, Pachana-deepana with Vaiswanara choornam
(6gm) along with hot water twice daily after food is given to enhance agni for the first 2 days, then Snehapana with Triphala gritha (30-150 ml depending on agni) is given in the early morning for the next 5 days.
Hot water is to be taken sip by sip after taking the ghee. After Snehapana, (for 5 days) Asanavilwadi Taila is given for anointing the body prior to hot water bath (2days). Next day, Virechanam is done with Trivrut lehya (15-50gm-based on koshta) which is mentioned in kaphaja timira chikitsa. From the next day onwards, Nasya with Anutaila will be done for the next 5 days & Vimala Varthi Anjana will be done for the last 30 days. Also Triphala choornam with ½ tsp Gogrita (Ghee) and 1 tsp Madhu (Honey) at night after food will be administered internally during the treatment course (30days) and at the end of the treatment, again subjective and objective parameters will be assessed and recorded.

After the completion of treatments (for 45 days), patients asked to come on 75th day (30th day of finishing the treatment) for the first assessment and the 105th day (60th of finishing the treatment) & 135th day (90th of finishing the treatment) to assess the sustained effect of the treatment.

 

 

 
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