| CTRI Number |
CTRI/2022/05/042712 [Registered on: 20/05/2022] Trial Registered Prospectively |
| Last Modified On: |
18/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Randomized controlled study.] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can we delay the near vision defect by Ayurveda |
|
Scientific Title of Study
|
“Randomized open labeled controlled parallel group add on
clinical atudy to assess the efficacy of Shatavaryadi churna
along with spectacles correction in the managemant of Dwitiya
Patalgat Timira with special reference to Presbyopia†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srishti Vyas |
| Designation |
PG Scholar |
| Affiliation |
Padamshri Dr DY Patil School of Ayurveda Nerul. Thane, Navi mumbai |
| Address |
DY Patil School of Ayurveda, 1st Floor, opd no: 4, Dept of shalakya Tantra, block no.10, DY Patil Vidyanagar, sector 7, nerul
DY Patil School of Ayurveda, 1st Floor, opd no: 4, Dept of shalakya Tantra, block no.10, DY Patil Vidyanagar, sector 7, nerul
Thane
MAHARASHTRA
400706
India |
| Phone |
9406619494 |
| Fax |
|
| Email |
svyasujn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Patil |
| Designation |
Head of the Department |
| Affiliation |
Padamshri Dr DY Patil School of Ayurveda Nerul. Thane, Navi mumbai |
| Address |
DY Patil School of Ayurveda, 3rd Floor, Dept of shalakya Tantra, block no.10, DY Patil Vidyanagar, sector 7, nerul
DY Patil School of Ayurveda, 3rd Floor, Dept of shalakya Tantra, block no.10, DY Patil Vidyanagar, sector 7, nerul
Thane
MAHARASHTRA
400706
India |
| Phone |
8108128018 |
| Fax |
|
| Email |
drashwinipatil14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Patil |
| Designation |
Head of the Department |
| Affiliation |
Padamshri Dr DY Patil School of Ayurveda Nerul. Thane, Navi mumbai |
| Address |
DY Patil School of Ayurveda, 1st Floor, opd no: 4, Dept of shalakya Tantra, block no.10, DY Patil Vidyanagar, sector 7, nerul
DY Patil School of Ayurveda, 1st Floor, opd no: 4, Dept of shalakya Tantra, block no.10, DY Patil Vidyanagar, sector 7, nerul
Thane
MAHARASHTRA
400706
India |
| Phone |
8108128018 |
| Fax |
|
| Email |
drashwinipatil14@gmail.com |
|
|
Source of Monetary or Material Support
|
| DY Patil School of Ayurved and Hospital, DY Patil Vidyanagar, Sector 7, Nerul-400706 |
|
|
Primary Sponsor
|
| Name |
Dr Srishti Vyas |
| Address |
DY Patil School of Ayurved and Hospital, DY Patil Vidyanagar, Sector 7, Nerul-400706 |
| 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 Srishti Vyas |
DY Patil School of Ayurveda |
1st Floor, opd no: 4, Department of Shalakya tantra, block no.10. DY Patil vidyanagar, Sector 7, Nerul-400706
Thane
MAHARASHTRA |
9406619494
svyasujn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: shatavaryadi churna , Reference: sholka 218-220, netra roga chikitsa, yogaratnakara with vaidyaprabha, hindi commentary, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: madhu, ghrutha), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | spectacles | convex glasses, according to age |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
i)Patients willing to participate in this trial through written informed consent.
ii) Patients who are 35 years to 45 years of age and from any sex.
iii) Patients having specific symptoms of Dwitiya Patalagata Timira.
iv) Emmetropia. |
|
| ExclusionCriteria |
| Details |
i)A person with age below 35 years and above 45 years.
ii) Presbyopia associated with systemic disorders and ocular pathology.
iii) Presbyopia with cataract.
iv) Persons with myopia and hypermetropia.
v) Persons who are not willing to give their written conset. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in near vision, |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/05/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE OF DISSERTATION
“RANDOMIZED OPEN LABELED CONTROLLED PARALLEL GROUP ADD ON CLINICAL STUDY TO ASSESS THE EFFICACY OF SHATAVARYADI CHURNA ALONG WITH SPECTACLES CORRECTION IN THE MANAGEMENT OF DWITIYA PATALGAT TIMIRA WITH SPECIAL REFERENCE TO PRESBYOPIAâ€
Aim: To evaulate the efficacy of Shatavaryadi Churna in Dwitiya patalgata Timira with special reference to Presbyopia.
Objective:- 1) Review of Aetiopathogenesis of Dwitiya Patalgata Timira in Ayurveda as well as in Modern. 2) To evaluate efficacy of Shatarvaryadi Churna orally in Dwitiya Patalgata Timira. 3) To review the relevant literature on Dwitiya Patalgata Timira and presbyopia in Ayurvedic and modern science prospective.
RESEARCH QUESTION
• Is Shatavaryadi Churna is effective in the management of Dwitiya Patalgata Timira with special reference to Presbyopia?
HYPOTHESIS
Null hypothesis H 0 :
• Shatavaryadi Churna is not effective in the management of Dwitiya Patalgata Timira (Presbyopia).
Alternative hypothesis H 1 :
• Shatavaryadi Churna is effective in the management of Dwitiya patalgata Timira (Presbyopia). Diagnostic Criteria: Objective parameter: 1. Visual Acuity and logMAR (,jagger’s) 2. Amplitude of accomodation 3. K1 And K2 Values (Autokeratometry) 4. lens thickness (A scan) 5. RAF Rule (NPA) Subjective parameter: All the symptoms and signs of Dwitiya Patalagata Timira (Presbyopia) will be assessed before and after the treatment. Symptoms are – 1. Blurred vision 2. Difficulty in near vision 3. Eye strain 4. Headache 5. Watery discharge MATERIAL AND METHODS: MATERIALS • A) Shatavaryadi Churna • B) Spectacles correction Sop of Shatavaryadi churna: Shatavaryadi churna will be prepared as per the reference in the Yog Ratanakar, netra rogadhikar Adhaya, Shloka No.218 to220. Here Acharya have advised to take ingredients in Churna form in which Shatavari churna is taken in 12 parts, Ela in 10 parts, Vaiyvidanga in 8 parts, Amalaki in 6 parts, Maricha in 4 parts, Pippali in 3 parts. The fine Powder (churna) will be prepared according to Sharangdhara Samhita Churna Kalpana. DOSE: 3gms BD (before meal) ANUPANA: Madhu(1/2) ghrutha (2times of madhu) KAALA: 2times a day DURATIONS: 3months B) Spectacles correction: Spectacles will be given according to patients need: (Corrected with convex lenses) At 40 years of age +1.00 correction is required At 45 years of age +1.50 correction is required |