| CTRI Number |
CTRI/2025/09/094552 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To check effect of Manshiladi Anjana in Eyes Disease like Blurring of vision |
|
Scientific Title of Study
|
AN OPEN LABLE RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF MANSHILADI ANJANA IN PRATHAMA PATALGATA TIMIRA (SIMPLE MYOPIA)” |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof DrAnupama Patra |
| Designation |
professor |
| Affiliation |
Shri Baba Mastnath Ayurveda college and Hospital |
| Address |
Department of Shalakya Tantra,
Shri Baba Mastnath Ayurveda college and Hospital,BMU, Asthal Bohar,Rohtak Haryana
Pin no-124021
Rohtak
HARYANA
124021
India |
| Phone |
8826948934 |
| Fax |
|
| Email |
dranupamapatra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Praveen Kumar Pandey |
| Designation |
Assistant Professor |
| Affiliation |
R. B Ayurvedic Medical College |
| Address |
OPD no 6 R B Ayurvedic medical college Mudi churaha Agra utter Pradesh
Agra
UTTAR PRADESH
283126
India |
| Phone |
8962910267 |
| Fax |
|
| Email |
praveen964296@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Praveen Kumar Pandey |
| Designation |
Assistant Professor |
| Affiliation |
R.B Ayurvedic Medical College |
| Address |
OPD no 6 R B Ayurvedic medical college Mudi churaha Agra Utter Pradesh
Agra
UTTAR PRADESH
283126
India |
| Phone |
8962910267 |
| Fax |
|
| Email |
praveen964296@gmail.com |
|
|
Source of Monetary or Material Support
|
| S G T university Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India |
|
|
Primary Sponsor
|
| Name |
Dean S.G. T institute of ayurveda |
| Address |
S G T university Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India. |
| 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 |
| Praveen Kumar Pandey |
R. B Ayurvedic Medical College |
OPD no 6 R B Ayurvedic medical college Mudi churaha Agra Utter Pradesh
Agra
UTTAR PRADESH |
08962910267
praveen964296@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe S.G.T University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H00-H59||Diseases of the eye and adnexa. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MANSHILADI ANAJNA , Reference: SUSHRUT UTTER 100/18, Route: Ocular, Dosage Form: Churna/ Powder, Dose: 125(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: WE WILL DO ANAJNA KARMA | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: CHANDANADI ANJANA , Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
36.00 Year(s) |
| Gender |
Both |
| Details |
patient presenting with pratham patalgat timira
patient taken with the symptom of blurring of vision, headache, watering from eye ,age 12years to 36 years with correction -3ds |
|
| ExclusionCriteria |
| Details |
patient who have not pratham patalgat timira,eye correction more thane -3ds,kmown case of HTN , DM etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptom like blurring of vision,eye strain , headche,watreing of eye |
20 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief From Symptom like blurring of vision ,Eye strain, headache, Watering of eyes |
20 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/10/2025 |
| 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="9"
Months="0"
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
|
Eye disorders are most commonly seen now a days due to various etiological conditions. Being one of the prime sensory organs, the protection of eyes is given much importance in all phase of science. 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. Timira or Myopia is the most common eye disease prevailing on a large scale. It is associated with blurred vision and asthenopic (eye fatigue) symptoms which are; headache, eye strain and watering in eyes. These adversely affect the overall quality of life of the individuals. For its management, classical therapies mentioned in our ancient literature need to be re-established today. |