| CTRI Number |
CTRI/2025/12/099025 [Registered on: 12/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Effectiveness of Oral Ayurvedic Medicines and Local Ayurvedic Applications in the Management of Myopia |
|
Scientific Title of Study
|
Randomised Open Controlled Clinical Trial To Assess The Efficacy Of Saptamrit Lauha Orally And Haridradivarti Anjana In Timira w.s.r. 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 Dattatraya Yalagi |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurvedic College , Kodoli, Dist. Kolhapur |
| Address |
MES Ayurved Mahavidyalaya, Ghanekhunt-Lote, Tal. Khed, Dist.- Ratnagiri
Yashwant Ayurvedic College , Kodoli, Dist. Kolhapur 416114
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9145204407 |
| Fax |
|
| Email |
drdattayalagi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Balasaheb Patil |
| Designation |
Associate Professor |
| Affiliation |
Yashwant Ayurvedic College , Kodoli, Dist. Kolhapur |
| Address |
Yashwant Ayurvedic College , Kodoli, Dist. Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7020519271 |
| Fax |
|
| Email |
dr.kp1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dattatraya Yalagi |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurvedic College, Kodoli, Kolhapur |
| Address |
MES Ayurved Mahavidyalaya, Ghanekhunt-Lote, Tal. Khed, Dist. Ratnagiri
Yashwant Ayurvedic College, Kodoli, Kolhapur
Kolhapur
MAHARASHTRA
415722
India |
| Phone |
09145204407 |
| Fax |
|
| Email |
drdattayalagi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yeshwant Ayurved College, Kodoli |
|
|
Primary Sponsor
|
| Name |
Yashwant Ayurvedic College , Kodoli, Dist. Kolhapur |
| Address |
NAYashwant Ayurvedic College , Kodoli, Dist. Kolhapur 416114 |
| Type of Sponsor |
Other [NA] |
|
|
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 Dattatraya Yalagi |
MES Parshuram Hospital, Yashwant Charitable Hospital |
Ghanekhunt-Lote, Mumbai-Goa Highway,Tal. Khed, Dist. Ratnagiri
Kodoli, Tal. Panhala, Dist. Kolhapur
Kodoli,
Ratnagiri
MAHARASHTRA |
09145204407
drdattayalagi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Comittee , MES Ayurved Mahavidyalaya, Ghanekhunt- Lote |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H53-H54||Visual disturbances and blindness. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amalakyadi Churna, Reference: Sushrut Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Koshna Jal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haridradi varti, Reference: Bhaishaya Ratnavali - Netrarogadhikar, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 1(), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: od, Reference: Abhakta, Route: 4 Weeks, Dosage Form: Varti/ Suppository, Dose: -(Anjana), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: Saptamrit Lauha, Reference: Bhaishajya ratnavali Shool Rogadhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -with 6 g honey and 12 g Ghrita), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients showing symptoms of Timir; Avyakta Darshana, Dwividha Darshana, Shirobhitapa, Netrayasa, Vihwala Darshana
2. Patients are selected irrespective of gender, socioeconomic state |
|
| ExclusionCriteria |
| Details |
1. Patients not willing for the trial were excluded
2. Patients having corneal opacity, iridocyclitis, infective disease, Traumatic Vision Loss and pathological myopia were excluded.
3. Patients suffering from systemic diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Blurred Vision (Avyakta Darshana),Improvement in Diplopia (Dwidha Darshana),Reduction in Headache (Shirobhitapa), Reduction in Eye strain (Netrayasa),Reduction in Glare/Halo (Vihwala Darshana) |
Baseline, Week 2, Week 4, Week 6, Week 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/12/2025 |
| 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="0"
Months="2"
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
|
· Myopia commonly known as short-sightedness, is a type of refractive error and is a cause of visual impairment globally. The condition is increasingly prevalent due to lifestyle factors such as prolonged use of computers, video games and screen exposure. In Ayurveda, Myopia closely resembles to Timira involving the first and second patal based on clinical presentation, anatomical structures and disease pathogenesis. · This study aims to evaluate the clinical efficacy of saptamrit Lauha (oral) and Haridradivarti anjana (topical) in patients of Timir (Myopia). The study adopts an integrative approach to manage both symptoms and the underlying cause of visual impairment. A randomised controlled trial will be conducted on 200 patients diagnosed with myopia. Participants will be divided in two groups (n = 100 each). Group A will be treated with Haridradivarti anjana (topical) and Saptamrit Lauha (Orally); while Subjective parameters include - Blurred vision (Avyakta darshan), Diplopia (Dwidha darshan), Headache (Shirobhitap), Eye Strain (Netrayasa), Visual Distortions (Vivhala Darshana). Objective parametrs include Visual Acuity, Autorefractometry, Ophthalmoscopy and A-Scan. Treatment outcomes will be assessed at regular intervals- on Day 7, 21, 35, 49 and 60. The trial will be conducted at MESAM Parshuram Hospital, Lote, Tal. Khed, Dist. Ratnagiri. Data will be analysed statistically using appropriate methods. Observation and results will be discussed with subject experts, tabulated and conclusions drawn based on evidence obtained. ·
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