CTRI/2021/12/038889 [Registered on: 23/12/2021] Trial Registered Prospectively
Last Modified On:
08/03/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Biological Ayurveda Preventive
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical study to see the effect of some Ayurvedic formulation in the treatment of far sightedness.
Scientific Title of Study
RANDOMIZED CONTROLLED CLINICAL TRIAL ON COMBINATION OF BHASKAR GHRITA NASYA AND SAPTAMRITA LAUHA IN MANAGEMENT OF PRATHAMA-DWITIYA PATALGATA TIMIR w.r.t HYPERMETROPIA
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Vd Sayali Sahas Patil
Designation
MS Scholar Shalakyatantra (Ayurved)
Affiliation
Sumatibhai Shah Ayurved Mahavidyalaya
Address
OPD no. 09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune Department of Shalakyatantra, MAMs Sumatibhai Shah Ayurved College, Hadapsar, Pune Pune MAHARASHTRA 411028 India
Phone
8097480795
Fax
Email
sayalipatil661@gmail.com
Details of Contact Person Scientific Query
Name
DR PRAVIN M BHAT
Designation
Associate Professor
Affiliation
Sumatibhai Shah Ayurved Mahavidyalaya
Address
OPD no. 09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune Department of Shalakyatantra, MAMs Sumatibhai Shah Ayurved College, Hadapsar, Pune Pune MAHARASHTRA 411028 India
Phone
09860233173
Fax
Email
vdpravin82@gmail.com
Details of Contact Person Public Query
Name
DR PRAVIN M BHAT
Designation
Associate Professor
Affiliation
Sumatibhai Shah Ayurved Mahavidyalaya
Address
OPD no. 09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune Department of Shalakyatantra, MAMs Sumatibhai Shah Ayurved College, Hadapsar, Pune
MAHARASHTRA 411028 India
Phone
09860233173
Fax
Email
vdpravin82@gmail.com
Source of Monetary or Material Support
Department of Shalakyatantra, Sane Guruji Arogya Tantra, Malwadi road, Hadapsar, Pune.
1. Patients having symptoms of Prathama Dwitiya Patalgata Timir will be included.
2. Patients who have ≤ +5 D in both the eyes
3. The patient age from 18 years to 60 years of age
4. Patient having vision of 6/9 or less i.e., 6/12, 6/18,6/24, 6/36, 6/60.
5. Patient yogya for Nasya Karma.
6. Patient of either gender will be included in the study.
ExclusionCriteria
Details
1. Patients having symptoms of Tritiya and Chaturtha Patalgata Timir will be excluded like Kacha and Linganasha.
2. Patient suffering from infectious disease e.g.-viral, bacterial or fungal conjunctivitis, blepharitis and trachoma.
3. Patient having known case of Hypertension, HIV, TB, Rheumatic Heart Disease, Bronchial Asthma, Thyroid disorder.
4. Hypermetropia associated with other ocular disease such as cataract, glaucoma, retinal disease, chorioretinitis, iridocyclitis, choroidal disease, vitreal opacity, cornel opacity, corneal ulcer.
5. Congenital, Acquired non physiological hypermetropia like index hyermetropia, pseudophakic hypermetropia.
6. Refractive errors like astigmatism, myopia, presbyopia and other ocular pathologies will be excluded.
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
A clinical study to evaluate efficacy of Bhaskar Ghrita Nasya and Saptamrita Lauha Vati in Prathama and Dwitiya Patalgata Timir w.r.t Hypermetropia. Parameter of efficacy will be visual acuity before and after treatment
Follow up will betaken on 1st, 11th and 21st day. Parameter of efficacy will be visual acuity before and after treatment
Secondary Outcome
Outcome
TimePoints
A comparison between efficacy of Bhaskar Ghrita Nasya with Saptamrita Lauha and Saptamrita Lauha alone in Prathama and Dwitiya Patalgata Timir w.r.t Hypermetropia
Total duration of the study will 18 months.
Target Sample Size
Total Sample Size="56" Sample Size from India="56" Final Enrollment numbers achieved (Total)= "56" Final Enrollment numbers achieved (India)="56"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
1. The progress of the disease Timira has mentioned in terms of involvement of successive Patalas (layers of eyeball). When the vitiated Doshas invades first Patala, the patient complains of difficulty in distance vision and if not treated it shifts to next patala. 2. Visual disturbance is represented as one of the most complex problem in the field of ophthalmology and it has a great interest ever since the dawn of human life[5]. 3. Hypermetropia is that form of refractive error in which parallel rays of light are bought to a focus some distance behind the sentient layer of the retina when the eye is at rest, the image formed here is therefore made up of circles of diffusion of considerable size, and is consequently blurred [6]. 4. Small amount of hypermetropia in young patients up to +0.50 D for distant is usually corrected by their accommodation, without any defects in vision .If the hypermetropia is high i.e., above +1D there will be defective vision for both distance and near. 5. People may also experience accommodative dysfunction, binocular dysfunction, strabismus and amblyopia. In modern science use of spectacles, contact lenses, laser in situ, keratomiesis, refractive keratometry is been advised. But these all have some limitations. These doesn’t prevent the pathology of refractive error so the blurring of vision continues .Surgeries are costly for everyone and at the same time this operations have some complications.
Bhaskar Ghrita Nasya is an easy and affordable procedure, and also it prevents pathology of Timir, whereas Saptamrita Lauha is best drug to prevent the pathology of Timir. Dravyas included in Bhaskar Ghrita yoga are Yastimadhu, Draksha, Mishri (Khanda),Pippali. Acharya Vangsena has described Bhaskar Ghrita which is selected for study .Dravyas included in Saptamrita Lauha are Yastimadhu, Amalaki, Bibtaki, Haritiki and Lauha Bhasma. In Bhaishajya Ratnavali Saptamrita Lauha has been described in chapter 64 Netra Roga. Purpose of study is to find out solution for Prathama and Dwitiya Patalgata Timir.