CTRI Number |
CTRI/2022/04/041862 [Registered on: 13/04/2022] Trial Registered Prospectively |
Last Modified On: |
12/04/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Physiotherapy (Not Including YOGA) |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
“In Simple Myopia effect of haritkyadi eye drops and eye exercises study" |
Scientific Title of Study
|
An Open Labelled Randomised Controlled Clinical Trial To
Evaluate The Adjuvant Effect Of Haritkyadi Eye Drops And Eye Exercises In Prathama Patalgata Timira With Special
Refrences To Simple Myopia.’ |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Manjiri Keskar |
Designation |
Professor |
Affiliation |
Parul Institute of Ayurveda |
Address |
OPD-108,Parul Ayurveda hospital, shalakya tantra department, Parul
institute of Ayurveda,Parul University, At Post-Limda, Tal- Waghodia,
VADODARA, Gujarat. 391760
Vadodara GUJARAT 391760 India |
Phone |
9822606358 |
Fax |
|
Email |
manjirikeskar@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Priyanka Satapathy |
Designation |
PG Scholar |
Affiliation |
Parul Institute of Ayurveda |
Address |
OPD-108,Parul Ayurveda hospital, shalakya tantra department, Parul
institute of Ayurveda,Parul University, At Post-Limda, Tal- Waghodia,
VADODARA, Gujarat. 391760
Vadodara GUJARAT 391760 India |
Phone |
8328845165 |
Fax |
|
Email |
mail2priyankasatapathy@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Priyanka Satapathy |
Designation |
PG Scholar |
Affiliation |
Parul Institute of Ayurveda |
Address |
OPD-108,Parul Ayurveda hospital, shalakya tantra department, Parul
institute of Ayurveda,Parul University, At Post-Limda, Tal- Waghodia,
VADODARA, Gujarat. 391760
Vadodara GUJARAT 391760 India |
Phone |
8328845165 |
Fax |
|
Email |
mail2priyankasatapathy@gmail.com |
|
Source of Monetary or Material Support
|
Parul Ayurveda hospital, parul university, at P. O limda, Tal- waghodiya, vadodara- 391760 |
|
Primary Sponsor
|
Name |
Dean Parul institute of Ayurveda |
Address |
Parul Ayurveda hospital, Parul University, At P.O-Limda, Tal-
Waghodia, VADODARA-391760 |
Type of Sponsor |
Private medical college |
|
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 |
Priyanka SATHPATHY |
Parul Institute of Ayurveda |
OPD-108, parul Ayurveda hospital, shalakya tantra department, parul university, aat P. Ke limda, Tal- waghodiya, vadodara, 391760 Vadodara GUJARAT |
8328845165
mail2priyankasatapathy@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethical committee |
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 | Drug | Classical | | (1) Medicine Name: Haritakyadi eye drop, Reference: Vangasen36/326, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 0.70(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 14 Days, Reference: , Route: , Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: 14 Days, Reference: , Route: , Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | 2 | Comparator Arm | Procedure | - | Eye exercises | (Procedure Reference: 10. Bates WH. “Perfect eye sight without glasses†1st Edition 1919. Available from www.eyesightimprovenaturally.com. , Procedure details: Eye wash, Prayer, Deep Breathing, Palming, Shifting the Near and Far Focus, Clock rotation
1. Eye wash-Before commencement of Eye exercise.
2. Prayer-
3. Deep Breathing-5 times
4. Shifting the Near and far focus-10 times
5. Clock and anti clock wise rotation-10 times 6. Palming-10 times sop of eye exercise will be given to all the subjects enrolled and will be demonstrated on 1st days under the supervision of PG scholar and guide.
)
|
|
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
30.00 Year(s) |
Gender |
Both |
Details |
1. Patients presenting with classical features of prathama patalagata timira.
2. Presenting presenting with asthenopic symptoms.
3. With correction <-3Ds
4. Those who are fit for Anjana.
Those who give assent or consent, as per requirement. |
|
ExclusionCriteria |
Details |
1.Dwitiya, Trutiya and Chaturtha Patalagata Timira
2.With correction > -3 Ds
3.Patients with ocular manifestations due to serious systemic illness.
4. Patient underwent any of the ophthalmic surgeries.
• Those contraindicated for Anjana.
• Patient with astigmatism will be excluded.
• Known cases of Hypertension, Diabetes etc… |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Preparation of Haritakyadi eye drops which is reduced symptoms like :Blurring of vision
,
Eye strain, Headache ,Watering of eyes |
3 month and 12 week |
|
Secondary Outcome
|
Outcome |
TimePoints |
Intervention of Haritakyadi eye drop and eye exercise |
10 month |
Intervention of eye exercises which is reduced symptoms like : blurring of vision, eye strain, Headache, watering from eyes. |
10 month |
|
Target Sample Size
|
Total Sample Size="104" Sample Size from India="104"
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 |
Date of First Enrollment (India)
|
01/05/2022 |
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
|
• In Ayurveda, Timira is described as one among the Patalagata Vikruti Lakshana.Netra is given the prime importance among all the Indriyas. • “दà¥à¤°à¥à¤·à¥à¤Ÿà¤¿à¤¶à¥à¤šà¤¨à¤¿à¤¾à¤·à¥à¤Ÿà¤¿à¤·à¥à¤Ÿà¤¿à¤§à¤‚जगचà¥à¤šà¤¤à¤®à¥‹à¤®à¤¯à¤‚जायतà¤à¤•रà¥à¤ªà¤®à¥"[अ. हà¥. सà¥à¥¨à¥ª/२३] • Acharya Vagbhatta, quoted in Ashtanga Hrudaya sincere efforts should be made by every individual to preserve hisher vision till the last breath of life, because, for an individual who is blind, day and night are the same and this beautiful world is of no use to him even if he possesses a lot of wealth. • So, if vision is lost merely everything is lost. All our daily activities depend on the quality of our vision. The loss of vision is nothing but the loss of life. • As described in the ayurvedic literature, Sushruta Samhita, our eyes consist of six Patalas; 2 Vartama Patalas and 4 Akshigolaka Patalas. The outer one of the four Akshigolaka patalas i.e. the first Patala is associated with Rasa and Rakta dhatu. It is supported by Tejas and Jala. 2 • Prathama Patalagata Timira is comparable to the most common refractive error i.e. Simple Myopia. It manifests as blurring of distant vision. Clinical features related to visual disturbance are seen only in Drishtigata Netra rogas, and hence all the errors of refraction can be co-related with Timira-Kaach-Lingnasha.. • Myopia or short-sightedness is a type of refractive error in which parallel rays of light coming from infinity are focused in front on the retina when accommodation is at rest.3 • According to the World Health Organisation (WHO)-prevalence of myopia in India is found to be 6.9%. in fact, vision 2020 which is foremost large scale program.4 • Overall reported prevalence is 20-40% of population.5 • There are various therapeutic procedures known as kriya-kalpa mentioned in our classical literature for its prevention and cure. • Anjana is one such simple, non-invasive procedure which can be easily done on the patients. • Eye exercises are relaxing techniques which are easy to perform and play an important role in strengthening and toning eye muscles. It also helps in restoration and improving eyesight |