| CTRI Number |
CTRI/2025/05/086656 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda
Preventive
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to see the effect of Ayurvedic formulation in the treatment of childrens farsightedness(Paediatric Myopia) |
|
Scientific Title of Study
|
A randomized controlled trial to evaluate efficacy of oral administration of Shadang Kwath Vati with spectacles in Pratham Dwitiya Patalagata Timir with reference to Paediatric 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 |
Vd Shubham Shamrao Bhilawade |
| Designation |
MS Scholar Shalakyatantra (Ayurved) |
| Affiliation |
Sumatibhai shah Ayurvedic Medical College Malwadi Hadapsar Pune |
| Address |
OPD No.9 ,Department Of Shalakyatantra,Sane Guruji Arogya Kendra,Malwadi Road, Hadapsar
Pune,
Maharashtra
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
7972909729 |
| Fax |
|
| Email |
shubham1k98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumedha Y Kotangale |
| Designation |
Associate Professor |
| Affiliation |
Sumatibhai shah Ayurvedic Medical College Malwadi Hadapsar Pune 411028 |
| Address |
OPD No 9 Department Of Shalakyatantra Sane Guruji Arogya Kendra Malwadi Road Hadapsar
Pune
Maharashtra
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
8275298480 |
| Fax |
|
| Email |
sumedhayk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumedha Y Kotangale |
| Designation |
Associate Professor |
| Affiliation |
Sumatibhai shah Ayurvedic Medical College Malwadi Hadapsar Pune |
| Address |
OPD No.9 ,Department Of Shalakyatantra,Sane Guruji Arogya Kendra,Malwadi Road, Hadapsar
Pune,
Maharashtra
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
8275298480 |
| Fax |
|
| Email |
sumedhak@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar,Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
165,Malwadi Road, Hadapsar, Pune, Maharashtra, India,411028 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shubham Shamrao Bhilawade |
Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune411028 |
OPD No.9 ,Department Of Shalakyatantra,Sane Guruji Arogya Kendra,Malwadi Road, Hadapsar
Pune,
Maharashtra
411028
India
Pune
MAHARASHTRA |
7972909729
shubham1k98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shadang Kwath Vati, Reference: Bharat Bhaishsajya Ratnakara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -guda), Additional Information: Shadang Kwath modified into vati form for palatibility | | 2 | Comparator Arm (Non Ayurveda) | | - | Spectacles | Spectacles will be given for continous use. |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient Enrolled with symptoms of Prathama-Dwitiya Patalagata Timira i.e. Avyaktam- ekshateroopam (visual hallucination), Vyaktamapyanimitta (transient nature of blurriness), Dooram-n-ekshate (difficulty of distant vision) in Shalakya OPD.
2)Age- 08 to 16 years.
|
|
| ExclusionCriteria |
| Details |
1)Patient who have symptoms of Tritiya and Chaturtha Patalagata Timira will be excluded
2)Congenital type of myopia, pathological type of myopia, acquired or secondary type of myopia that occurs due to some factors or diseases i.e. post traumatic, drug induced, post keratitis. etc. will be excluded
3)Myopia associated with other ocular diseases like cataract, glaucoma,etc
4)Patient who have myopia associated with other refractive errors such as astigmatism
5)Patient who have known case of hypertension, diabetes mellitus, Rheumatic arthritis or any other arthritic conditions, rheumatic heart disease, thyroid disorder, asthma, Koch’s, HIV will be excluded
6)Patient who have active infectious diseases i.e. viral, fungal, bacterial conjunctivitis, trachoma, blepharitis
|
|
|
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 |
To study the efficacy of oral administration of Shadang Kwath Vati in the management of Pratham Dwitiya Patalagata Timir with reference to Paediatric Myopia which will be assesed on the basis of visual acuity with uncorrected and best corrected visual acuity.
|
The total duration of treatment for each patient will be 30 days with follow up on 0th, 15th and 30th day with an observational follow up on 45 th day. The effect will be assessed before and after treatment on the basis of uncorrected and best corrected visual acuity. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of oral administration of Shadang Kwath Vati with a spectacles in Pratham Dwitiya Patalgata Timira w.r.t. Paediatric Myopia which will be assessed on the basis of Visual Acuity under uncorrected & best corrected visual acuity. |
Total duration of study is 18 Month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/05/2025 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Myopia also called as Near-sightedness or Shortsightedness is a common eye condition in which the image seen by the eye is focused prior to the retina. This produces an unfocused image on the retina which is seen by the patient as a blurred image.Ayurveda gives prime importance to the eyes, as Acharya says, “Sarveindriyanaam Nayanam Pradhaanam”. Therefore, it is important to care of eyes and for that purpose, obtain knowledge related to eyes i.e. physiological and pathological knowledge Timira is characterized by Avyaktamekshateroopam, Vyaktamapyanimitta, Dooramnekshate. These signs and symptoms are more similar to myopia. The signs and symptoms of myopia are blurred vision, difficult to see distant objects and visual hallucination.According to Ayurveda Samhitas, Timira is Aushadha Sadhya Vyadhi. Haritaki is Pitta-Kapha Shamak and Deepaniya, Chakshushya. Amalaki is one of the Chakshushya and Rasayan drug. Nimba is mentioned as a Netrya. Amruta is Rasayani, Balya and Tridoshnashak. So oral administration of “Shadang Kwath-Vati” is selected for the study. Acharya, stated that Shadang Kwath Vati can be used in Patalagata Rogas and also acts as Chakshushya.
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