| 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
|
|
|
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
|
|
|
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.
|