| CTRI Number |
CTRI/2024/07/070085 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study To See The Effect Of Nasal Drops Of Vayasthapak Mahakashaya Siddha Ghrita In The Management Of Presbyopia |
|
Scientific Title of Study
|
A Single arm study to evaluate efficacy of Vayasthapaka Mahakashaya Ghrita Nasya in Presbyopia |
| 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 Anand Vikram Kale |
| Designation |
Assistant Professor PhD Scholar Shalakya Tantra |
| Affiliation |
Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 |
| Address |
OPD no 6 Netra Division Department of Shalakyatantra Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9890628486 |
| Fax |
|
| Email |
vdanandkale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayur V Shiralkar |
| Designation |
Professor and HOD Shalakyatantra |
| Affiliation |
Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 |
| Address |
OPD no 6 Department of Shalakyatantra Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9422007951 |
| Fax |
|
| Email |
mayur.shiralkar@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Vikram Kale |
| Designation |
Assistant Professor PhD Scholor Shalakyatantra |
| Affiliation |
Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 |
| Address |
OPD no 6 Netra Division Department of Shalakyatantra Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9890628486 |
| Fax |
|
| Email |
vdanandkale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College Of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Anand Vikram Kale |
| Address |
Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 |
| 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 Anand Vikram Kale |
Dr D Y Patil College Of Ayurved And Research Centre |
OPD NO 6 Department Of Shalakyatantra Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA |
9890628486
vdanandkale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H524||Presbyopia. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Sharangdhar Samhita, Procedure details: Medicated Ghee will be instilled through nasal route in form of drops . Two drops per day for 7 days.)
(1) Medicine Name: Vayasthapak Mahakashaya Siddha Ghrita, Reference: Charak Samhita, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients who are having complaints of loss of ability to comfortably view near objects
2 Between the age group of 40 to 65 years will be included in the study
|
|
| ExclusionCriteria |
| Details |
1 Patient not willing for trial
2 Patients suffering from infectious conditions
of the eye like scleritis uveitis glaucoma
etc
3 Patient who need surgical and other
interventions
4 Patients which are on drugs such as aspirin
and sulfonamides which are known to affect
ciliary spasm
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess The Efficacy Of Vayasthapak Mahakashaya siddha Ghrita Nasya In Improving The Amplitude Of Accomodation For The Near Vision In Presbyopic Patients |
15 Days with Three Assessments
( 0th 7th 15th ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of "VAYASTHAPAK MAHAKASHAYA
"Siddha Ghrita Nasya in improving the near vision of Presbyopic patient at different time intervals. |
15 Days with Three Assessments
( 0th 7th 15th ) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="6"
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
|
The Aim of study is to assess the efficacy of Vayasthapak Mahakashaya Siddha Ghrita Nasya in the management of Presbyopia
The study will be conducted on 50 patients showing signs and symptoms of Presbyopia
They will be instilled 2 drops of Vayasthapak Mahakashaya Siddha Ghrita Nasya in each nostril for a duration of 15 days and assessment will be done on o th 7th and 15th day and Final conclusion will be drawn on the basis of proper Statistical methods |