| CTRI Number |
CTRI/2014/01/004357 [Registered on: 28/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
04/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
management of immature cataract (timira) with triphaladi compound and elaneer kuzhambu anjana |
|
Scientific Title of Study
|
Further clinical study on evaluation of anti-cataract effect of Triphaladi Compound and Elaneer Kuzhambu in immature cataract w.s.r. Timira |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hitesh Bhati |
| Designation |
Research Scholar |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
8141420826 |
| Fax |
|
| Email |
hitesh013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majusha Rajgopala |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9428400759 |
| Fax |
|
| Email |
bhatrajma2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hitesh Bhati |
| Designation |
Research Scholar |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
8141420826 |
| Fax |
|
| Email |
hitesh013@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda Gujrat Ayurved University Jamnagar-361008 |
|
|
Primary Sponsor
|
| Name |
IPGT AND RA GAU |
| Address |
IPGT AND RA GAU JAMNAGAR |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Hitesh Bhati |
Department of Shalakyatantra |
OPD no.4 Institute for Post Graduate Teaching and Research in Ayurveda Gujrat Ayurved University Jamnagar- Postal Code-361008
Jamnagar
GUJARAT |
8141420826
hitesh013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IPGT and RA Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients having Senile Immature Cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Triphaladi yoga |
Group A – Patients in the group will receive only Triphaladi yoga internally during three months of study. |
| Comparator Agent |
Triphaladi yoga as internal medicine and Elaneer kuzhambu as anjana |
Group B – Patients in the group will receive Triphaladi yoga as internal medicine and Elaneer kuzhambu as anjana during three months of study. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Men and women 20 in each arm who meet the diagnostic standards of Immature Cataract
2. aged 35- 60 years of age are included in this study. |
|
| ExclusionCriteria |
| Details |
Subjects who are suffering from-
1. congenital Cataract
2. mature and hyper mature Cataract
3. Glaucoma
4. Diabetic Retinopathy
5. Macular degeneration
6. Retinitis pigmentosa
7. whose RBS and Blood Pressure are not within normal limits
8. who are under steroid treatment & or any kind of Immunosuppressive therapy or
9. under any Cataract inducing medication are excluded from this study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Review of aetiopathogenesis of Timira as well as in modern literature and to establish a correlation with Cataract.
2. To assess the efficacy of test drugs as anti-Cataract agents in the clinical trial.
|
1. Conceptual Study- Till June 2014
2. Clinical Study- Till March 2015 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compile all the information related to the test drugs Elaneer kuzhambu anjana and Triphaladi yoga. |
1. Conceptual Study- Till June 2014
2. Clinical Study- Till March 2015 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Senile Cataract is the most common type of Cataract which is age related, that contributes to as much as 75 % of blindness in India, generally affecting persons of age more than 50 years. While surgery remains the only accepted treatment of Cataract, Immature Cataract in many cases is not handled properly. Surgery, although an effective means of cure Cataract has not however eliminated the current problem leading to blindness due to many reasons. 1. Long waiting list 2. Cost of Surgery 3. Risk of Complications 4. Lack of Technical hand and Equipments In such a scenario, a study on Immature Cataract management gains much importance and therefore this endeavour. Among many anti Cataract medicines Elaneer Kuzhambu is extensively used clinically in Kerala by local physicians, however, which has given good anti cataract effect in previous study.ref.
1. Triphaladi compound- is a ayurvedic medicine prepared with 11 ingredients which are given below
Triphaladi Compound
|
No
|
Drug
name
|
Botanical
name
|
Part used
|
Part
|
|
1.
|
Amalki
|
Emblica
officinalis
|
Fruit
|
1
|
|
2.
|
Haritaki
|
Terminalia
chebula
|
Fruit
|
1
|
|
3.
|
Bibhitaki
|
Terminalia
bellerica
|
Fruit
|
1
|
|
4.
|
Daruharidra
|
Berberis
aristata
|
Bark
|
1
|
|
5.
|
Haridra
|
Curcuma
longa
|
Rhizome
|
1
|
|
6.
|
Guduchi
|
Tinospora
cordifolia
|
Stem
|
1
|
|
7.
|
Gokshura
|
Trabulus
terrestris
|
Panchang
|
1
|
|
8.
|
Shunthi
|
Zingiber
officinale
|
Rhizome
|
1
|
|
9.
|
Punarnava
|
Boerhavia
diffusa
|
Root
|
1
|
|
10.
|
Yashtimadhu
|
Glycyrrhiza
glabra
|
Root
|
1
|
|
11.
|
Tulsi
|
Ocimum
sanctum
|
Leaf
|
1
|
2. Elaneer Kuzhambu- is again an ayurvedic medicine for eye. anjana is a group of medicines which are applied in eye with the help of a glass or metal rod. ingredients of elaneer kuzhambu is also an anjana and its ingredients are as follows as mentioned in Sahasrayogam an ancient ayurvedic book
Elaneer Kuzhambu
|
No.
|
Drug
|
Botanical name
|
Part used
|
Part
|
|
1.
|
Daruharidra
|
Berberis
aristata
|
Bark
|
1
|
|
2.
|
Haritaki
|
Terminalia
chebula
|
Fruit
|
1
|
|
3.
|
Bibhitaki
|
Terminalia
bellerica
|
Fruit
|
1
|
|
4.
|
Amalaki
|
Emblica
officinalis
|
Fruit
|
1
|
|
5.
|
Yashtimadhu
|
Glycyrrhiza
glabra
|
Root
|
1
|
|
6.
|
Narikela
|
Coccus
nucifera
|
jala
|
16
|
3. immature cataract w.s.r. timira-
timira is an ayurvedic group of diseases and immature catarct can be included in this
|