| CTRI Number |
CTRI/2021/03/032222 [Registered on: 23/03/2021] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic Treatment of diminished vision due to opacity in lens.
|
|
Scientific Title of Study
|
TO COMPARE THE EFFICACY OF PHALATRIKADI GHRITA WITH OR WITHOUT PATHYADI VARTI IN MANAGEMENT OF LINGANASHA W.S.R. TO IMMATURE SENILE 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 Sonia |
| Designation |
P G Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Shalakya Department, OPD No. 110, First Floor, Hospital Block, All
India Institute of Ayurveda, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India
South West
DELHI
110076
India |
| Phone |
8607892092 |
| Fax |
|
| Email |
dhingrasonia130@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjusha Rajagopala |
| Designation |
Head of Department |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Shalakya Department, 5th Floor, Administration Block, All India
Institute of Ayurveda, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India
South West
DELHI
110076
India |
| Phone |
9560788850 |
| Fax |
|
| Email |
hod-shalakya@aiia.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjusha Rajagopala |
| Designation |
Head of Department |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Shalakya Department, 5th Floor, Administration Block, All India
Institute of Ayurveda, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India
South West
DELHI
110076
India |
| Phone |
9560788850 |
| Fax |
|
| Email |
hod-shalakya@aiia.gov.in |
|
|
Source of Monetary or Material Support
|
| All india institute of ayurveda |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda 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 Sonia |
All India Institute of Ayurveda |
Shalakya Tantra department, OPD No. 110, First
floor, Hospital block.
South West
DELHI |
8607892092
dhingrasonia130@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: LINGANASAHA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pathyadi varti |
Local application of pathyadi varti from kaninika to apanga sandhi 60mgapprox. twice a day for 60 days.
|
| Comparator Agent |
Pathyadi varti along with phalatrikadi ghrita |
Oral administration of phalatrikadi ghrita 10ml (once a day) along with local application of pathyadi varti (60mg approx. twice a day) for 60 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having signs and symptoms of immature senile cataract described as per ayurvedic and modern texts.
2)Patients having vision not less than 6/60.
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing to participate in the clinical trial.
2. Patients having other systemic diseases or metabolic disorders such as hypertension, diabetic mellitus, thyroid, congenital cataract, diabetic retinopathy, macular degeneration,retinitis pigmentosa and any other illness necessitating long term treatment or under any kind of immunosuppressive therapy.
3. Patient is under any kind of cataract-inducing medications like corticosteroids, phenothiazines and miotics etc.
4. History of any surgical intervention to the eye.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in targeted symptom i.e. blurring of vision.
|
90 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in associated symptoms i.e. glare, diplopia, headache, glare, difficulty in night vision/dim light.
|
90 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/04/2021 |
| Date of Study Completion (India) |
25/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
one publication under process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Cataract is the major cause of blindness and visual impairment throughout the world and is likely to present an increasing burden to health care system. The World Health Organization estimates that 20 million people are blind from bilateral cataracts globally, with >90% of the world’s visually impaired living in developing countries. Acharya Sushruta has considered linganasha under twelve types of drishtigata rogas. According to sushruta timira, kacha, linganasha are the progressive stages of same diseases i.e. timira among all eye diseases is such a disease whose graves end result is linganasha. Timira stage of disease is produced when the vitiated doshas are situated in first, second and third patala, when disease are situated in fourth patala, linganasha occurs. This disease is also described in detail by Acharya vagbhatta in ashtangsanghrahya and hridya and merely follows sushruta. He has dealt the surgical aspect of disease in a separate chapter. In Contemporary science, there is no definite medical treatment for this condition in patients where surgical treatment is not suitable like uncontrolled diabetes, cardiac disorders, and so on. Alternatively, the preventive ophthalmology offers another approach to tackle the problem which might modify or simply delay the onset and progression of cataract. For that Ayurveda literature have recorded many compound formulation for the treatment of linganasha /Timira. The use of various herbs alone or herbo-mineral formulations as internally as well as externally as local eye drops, anjana, varties etc. to cure cataract are abundantly mentioned in many ayurvedic classic texts. As per Sushruta Samhita the proposed drug namely pathyadi varti kept in group I and oral admistration of phalatrikadi ghrita mentioned in vangasena Samhita kept in group II along with pathyadi varti to evaluate its effect on immature senile cataract. Study type – Interventional, comparative Masking – Randomised open labeled Purpose – Treatment Timing – Prospective End point – Efficacy No. of groups – Two groups Sample size – 40 (20 in each group) |