| CTRI Number |
CTRI/2024/08/073070 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
efficacy of Sougathanjanam collyrium in timira- simple myopia |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Sougathanjanam in Prathama patalagata timira( simple myopia) |
| 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 Sunitha P |
| Designation |
PG SCHOLAR |
| Affiliation |
Alva’s Ayurveda Medical College and Hospital |
| Address |
Department of P.G Studies in Shalakya Tantra,
Alva’s Ayurveda Medical College and Hospital,
Moodbidri, D.K District,
Karnataka-
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9633373294 |
| Fax |
|
| Email |
sunithap90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apeksha D Rao |
| Designation |
Professor and Head of Department |
| Affiliation |
Alva’s Ayurveda Medical College and Hospital |
| Address |
Department of P.G Studies in Shalakya Tantra,
Alva’s Ayurveda Medical College and Hospital,
Moodbidri, D.K District,
Karnataka-
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7411360991 |
| Fax |
|
| Email |
drapekshadrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apeksha D Rao |
| Designation |
Professor and Head of Department |
| Affiliation |
Alva’s Ayurveda Medical College and Hospital |
| Address |
Department of P.G Studies in Shalakya Tantra,
Alva’s Ayurveda Medical College and Hospital,
Moodbidri, D.K District,
Karnataka-
KARNATAKA
574227
India |
| Phone |
7411360991 |
| Fax |
|
| Email |
drapekshadrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| alvas ayurveda medical college and hospital, moodabidire, D.K, Karnataka 574227 |
|
|
Primary Sponsor
|
| Name |
Dr Sunitha p |
| Address |
Alva’s Ayurveda Medical College and Hospital,
Moodbidri, D.K District,
Karnataka-574227 |
| Type of Sponsor |
Other [self] |
|
|
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 Sunitha P |
Alvas Ayurveda Medical Hospital |
Department of Shalakya tantra
Alvas Ayurveda Medical College and hospital Moodubidire, 574227
Dakshina Kannada
KARNATAKA |
9633373294
sunithap90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee alvas Ayurveda Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: PRATHAMA-PATALAGATADOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: Sushrutha Samhita uttharatantra 17, Procedure details: local application as collyrium in both eyes)
(1) Medicine Name: Sougathanjanam, Reference: chakradatta 59/109, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 40(mg), Frequency: od, Duration: 48 Days |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients fulfilling the Diagnostic Criteria.
2)Patients between the age group of 05-21years.
3)Patients having dioptric power less than -6D. |
|
| ExclusionCriteria |
| Details |
1)Patients with, Dwiteeya, Triteeya and Chaturtha Patalagata Timira.
2)Patients having other Refractive errors except simple myopia.
3)Anjana Anarha
4)Patients with other systemic disorders that may interfere with the study.
ï‚· Patients with history of ocular trauma and surgeries.
ï‚· Patients with other ocular pathologies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in symptoms and 0.5d improvement in clinical refraction |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in unaided visual acuity |
96, 180 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/09/2024 |
| Date of Study Completion (India) |
30/06/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
For Simple Myopia optical treatment is commonly advised such as using spectacles, contact lenses and refractive surgeries . In Ayurvedic Classics various internal medications and Kriyakalpas has been explained to improve the vision and also to prevent the occurrence of disease. Anjana is one among the therapeutic procedure mentioned. Anjana Karma is a Kriyakalpa which is easy to apply, the medicines are easily available at a very affordable price. Hence the present study is conducted to evaluate the efficacy of Sougathanjanam in the management of Prathama Patalagata Timira (Simple Myopia) HYPOTHESIS ï‚· Hâ‚€- There is no statistically significant effect with Sougathanjanam in the management of Prathama Patalagata Timira. ï‚· Hâ‚- There is statistically significant effect with Sougathanjanam in the management of Prathama Patalagata Timir DIAGNOSTIC CRITERIA. ï‚· Patients with Lakshana of Prathama Patalagata Timira i.e., Avyaktha Darshana (Blurred Vision having dioptric power less than -6D and having Asthenopic symptoms like headache, eye strain and watering of eyes) Defective Distant Vision detected by ï‚· Snellen’s Distant Vision chart. ï‚· Auto refractometry. ï‚· Streak Retinoscopy INCLUSION CRITERIA ï‚· Patients fulfilling the Diagnostic Criteria. ï‚· Patients between the age group of 05-21years. ï‚· Patients having dioptric power less than -6D. EXCLUSION CRITERIA ï‚· Patients with, Dwiteeya, Triteeya and Chaturtha Patalagata Timira. ï‚· Patients having other Refractive errors except simple myopia. ï‚· Anjana Anarha9 ï‚· Patients with other systemic disorders that may interfere with the study. ï‚· Patients with history of ocular trauma and surgeries. ï‚· Patients with other ocular pathologies. intervention : Sougathanjanam, 1 harenu matra(40mg) for 48 days. total duration of the study is of 180 days. SUBJECTIVE PARAMETERS 1. Defective distant vision assessed by Snellen’s Distant Vision Chart. 2. Asthenopic Symptoms  Headache  Watering of eyes  Eye strain OBJECTIVE PARAMETERS 1. Auto Refractive Reading 2. Streak Retinoscope |