| CTRI Number |
CTRI/2024/03/063455 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management Of Timira - Immature Senile Cataract - A Randomized Controlled Clinical Trial |
|
Scientific Title of Study
|
Efficacy Of Chandrodaya Varti Anjana Along With Timirahara Lauha Orally In The Management Of Timira - Immature Senile Cataract - A Randomized Controlled Clinical Trial |
| 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 Sangita Shekhaliya |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department Of Shalakya Tantra, 5th Floor,Academic Block, All India Institute of Ayurveda, Mathura road,Gautampuri awas, Sarita vihar,New delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
8160693373 |
| Fax |
|
| Email |
sangitashekhaliya2610@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narayan Bavalatti |
| Designation |
Associate Professor,Department Of Shalakya Tantra |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department Of Shalakya Tantra, 5th Floor,Academic Block, All India Institute of Ayurveda, Mathura road,Gautampuri awas, Sarita vihar,New delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
9650715615 |
| Fax |
|
| Email |
eyenimi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangita Shekhaliya |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department Of Shalakya Tantra, 5th Floor,Academic Block, All India Institute of Ayurveda, Mathura road,Gautampuri awas, Sarita vihar,New delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
8160693373 |
| Fax |
|
| Email |
sangitashekhaliya2610@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda,
New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, Mathura road, Gautampuri, Sarita vihar,new delhi 110076 |
| 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 Sangita Shekhaliya |
All India Institute of Ayurveda, New Delhi |
OPD No. 110, 1st Floor, Hospital block,All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076
New Delhi
DELHI |
8160693373
sangitashekhaliya2610@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H259||Unspecified age-related cataract. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: Bhaisajya Ratnavali Netra Rogadhikar, Procedure details: Local Application from Kaneenika to Apanga sandhi
60 mg-BD
Morning-evening for 45 days
)
(1) Medicine Name: Timirahara Lauha, Reference: Rasendra Sara Sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 45 Days | | 2 | Comparator Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: Sahasrayogam, Netrarogadhikaram , Procedure details: Local Application from Kaneenika to Apanga sandhi
60 mg-BD
Morning-evening For 45 days
)
(1) Medicine Name: Triphaladi ghana vati, Reference: Anubhut Yoga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 45 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 patients having signs and symptoms of immature senile cataract described as per ayurvedic and contemporary texts
2 patients willing to take ayurvedic treatment
3 Visual Acuity better than or equal to 6/60 Snellen chart/ Log MAR 1
4 Senile immature cataract
|
|
| ExclusionCriteria |
| Details |
1 Congenital cataract,Traumatic cataract
2 Patients suffering from inflammatory and infectious disease of eyeball and its appendages
3 Hyper-mature and mature cataract
4 Patients is under / having history of using any cataract inducing medications like corticosteroids, phenothiazines and miotics drugs etc
5 History of any surgical intervention to eye
6 Patients having other systemic diseases or metabolic disorders or ocular diseases such as uncontrolled D.M., Diabetic Retinopathy, Macular Degeneration, Retinitis Pigmentosa and any other illness necessitating long term treatment or under any kind of immunosuppressive therapy
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of Avyakta Darshana (blurring of vision) in terms of Visual acuity |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Ocular toxicity of Chandodaya Varti Anjana
improvement of other associated symptoms like glare, diplopia, black spots in front of eyes, difficulty in day and night vision, headache
|
90 days |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/03/2024 |
| 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)
|
Not Yet Recruiting |
| 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
|
Cataract has been documented to be the most significant cause of bilateral blindness, both in India as well as on a global scale. Aging is the most common aetiological factor contributing to the disease cataract. The pathophysiology behind senile cataract is yet to be fully understood. Multiple mechanism contributes to loss of normal transparency in senile cataract. There is no universally accepted pharmacological agent that can either reverse or inhibit the progression of cataract. Globally, at least 2.2 billion people have a near or distance vision impairment. In at least 1 billion- almost half of these cases, vision impairment could have been prevented or has yet to be addressed. The leading cause of visual impairment and blindness are uncorrected refractive errors (88.4 million) and cataract (94 million).OBJECTIVE OF RESEARCH Primary Objective: § To evaluate the efficacy of local application of Chandrodaya Varti (approx. 60mg - BD for 45 days) along with Timirhara Lauha orally (500mg-BD) for 45 days in management of Timira - symptom i.e., Avyakta Darshana (blurring of vision) in terms of Visual acuity. Secondary Objective: § To evaluate the efficacy of local application of Chandrodaya Varti (approx. 60mg-BD for 45 days) along with Timirhara Lauha (500mg-BD for 45 days) in management of Timira on other associated symptoms like glare, diplopia, black spots in front of eyes, difficulty in day and night vision, headache. § To study the pharmacognostical and physico-chemical properties of Chandrodaya Varti Anjana and Timirahara Lauha. § To study the acute eye irritation/corrosive effect of Chandrodaya Varti Anjana if feasible.
|