| CTRI Number |
CTRI/2025/09/094563 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check Viddhakarma along with Shatavaryadi churna is effective or not effective in Timir wsr myopia |
|
Scientific Title of Study
|
A Single Arm Clinical Study To Evaluate The Therapeutic Efficacy Of Viddhakarma Along With Shatavaryadi Churna For Pratham Patalgata Timira (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 |
Dr Vaibhav Dongare |
| Designation |
PG Scholar Department of Shalakya Tantra |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no 54 Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
8976640255 |
| Fax |
|
| Email |
vadongare11714@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Kumar |
| Designation |
Professor Department of Shalakya Tantra |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no 106 Department of Shalakya Tantra Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9996310888 |
| Fax |
|
| Email |
drmanojtanwar23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Dongare |
| Designation |
PG Scholar Department of Shalakya Tantra |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no 54 Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
8976640255 |
| Fax |
|
| Email |
vadongare11714@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved studies and research Shri Krishna AYUSH university Umri road sec 8 Kurukshetra |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra |
| Type of Sponsor |
Other [Government Ayurved 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 |
| Vaibhav Dongare |
Institute for Ayurved studies and research |
Shri Krishna AYUSH university Umri road sec 8 Kurukshetra
Kurukshetra
HARYANA |
8976640255
vadongare11714@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAU KURUKSHETRA INSTITUTIONAL ETHICS COMMITTEE |
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 | Procedure | - | vedhana-karma, वेधन-कर्म | (Procedure Reference: Sushruta Samhita nibandhasangraha commentary by dalhanacharya edited by Vaidya yadavji trikabakji sharir sthana chapter 8 verse 6 to 20, Procedure details: The respective mentioned points Upanasika Lalata Apanga will be identified with the help of local Anatomy
The area should be disinfected with the help of spirit swab
With the help of Insulin Hollow needle no 26½ G 2 to 4 mm prick will be taken
Blood oozing out from prick site will be wiped with the help of sterile cotton swab
Used Needle will be disposed
Viddhakarma Procedure will be administered once every 3 days Following standard Guidelines throughout the intervention period of 30 days)
(1) Medicine Name: Shatavaryadi churna, Reference: Yogratnakar vidyotini Shastri shri Lakshmi shrilakshmipati netrarogadhikar page no 371 to 372, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
The person with age of greater than 18 years and Lower than 30 years
Myopia up to negative 3D Low myopia
Patients with sign and symptoms of Pratham patalgata Timira myopia will be
selected irrespective of Sex Religion and Profession
Clinical Features like Durastha Avyakta Darshana indistinct distant vision Vihwala
Darshana blurred vision Shirobhitapa headache Netrasrava watering
Patients those are fit for Vedhya Karma according to Ayurveda text
Patient willing to register for trial |
|
| ExclusionCriteria |
| Details |
Age group lower than 18 years and more than 30 years
Patients with Myopia greater than 3D
The patients with other eye diseases like Cataract Glaucoma and Allergic conditions
Patients having any other known ocular pathology and myopic degenerative changes
The patient having any systemic illness like Diabetes mellitus Hypertension etc
Patients suffering from head injury
Patients Contraindicated for Vedhya Karma
Pregnant and lactating mothers are avoided for study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in visual acuity measured by snellens chart readings after completion of treatment
Changes in measurement of axial length of eyeball and curvature of cornea |
1st - 0 day
2nd - 7th day
3rd - 28th day
4th - 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
01/12/2025 |
| 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="0" |
|
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
|
This clinical study titled A single arm clinical study to evaluate the therapeutic efficacy of Viddhakarma along with Shatavaryadi Churna for Pratham Patalgata Timir Myopia aims to assess the effect of Ayurvedic interventions on myopia a condition described as Timir in classical texts Myopia is a growing public health concern especially among the younger population and can lead to high or pathological myopia if untreated In this prospective study patients diagnosed with Timir will be managed with Viddhakarma a parasurgical procedure along with oral administration of Shatavaryadi Churna The therapeutic response will be evaluated using both objective parameters visual acuity refractive error axial length corneal curvature and subjective parameters eye strain blurring of distant vision headache watering The study is expected to demonstrate improvement in vision and reduction in symptoms thereby supporting the role of Ayurvedic measures in the management of Timir myopia |