| CTRI Number |
CTRI/2025/04/085910 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Karanjadi Rasakriya Anjana in Klinnavartma (Ulcerative Blepharitis) |
|
Scientific Title of Study
|
An open randomized control clinical trial of Karanjadi rasakriya anjana in Klinnavartma with special referance to Ulcerative Blepharitis |
| 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 Ajay Omprakash Kadam |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Research Center Ashta |
| Address |
Department of Shalakyatantra Hon Shri Annasaheb Dange Ayurved Medical College And Research Center Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
7972860998 |
| Fax |
|
| Email |
ajaykadam5896@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Deepak Kate |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Research Center Ashta |
| Address |
Department of Shalakyatantra Hon Shri Annasaheb Dange Ayurved Medical College And Research Center Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9404701645 |
| Fax |
|
| Email |
drsujatakate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Deepak Kate |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Research Center Ashta |
| Address |
Department of Shalakyatantra Hon Shri Annasaheb Dange Ayurved Medical College And Research Center Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9404701645 |
| Fax |
|
| Email |
drsujatakate@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College And Research Center Ashta Tal-Walwa Dist-Sangli Maharashtra 416301 India |
|
|
Primary Sponsor
|
| Name |
Dr Ajay Omprakash Kadam |
| Address |
OPD No 2 Netra Rog OPD Ground Floor Dhanwantari Ayurved Hospital Ashta Tal Walwa Dist Sangli |
| Type of Sponsor |
Other [self] |
|
|
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 Ajay Omprakash Kadam |
Hon Shri Annasaheb Dange Ayurved Medical College And Research Center Ashta |
OPD No 2 Netra Rog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
7972860998
ajaykadam5896@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H010||Blepharitis. Ayurveda Condition: VARTMA-ROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | a~jjanam, अंजनम् | (Procedure Reference: Sushrut Samhita, Procedure details: Once a day for 7 Days)
(1) Medicine Name: Karanjadi Rasakriya Anjana, Reference: Vagbhat, Route: Topical, Dosage Form: Varti/ Suppository, Dose: 3.9(mg), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | a~jjanam, अंजनम् | (Procedure Reference: Sushrut Samhita, Procedure details: Twice a day for 7 days)
(1) Medicine Name: Dhatryanjana, Reference: Sushrut, Route: Topical, Dosage Form: Varti/ Suppository, Dose: 3.9(mg), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Shows symptoms of Klinnavartma.
2. Patient with age aboven 18 yrs to 60 years will be included.
3. Patient irrespective of Gender, educational, socioeconomic,
marital status. |
|
| ExclusionCriteria |
| Details |
1. Any other active acute infective ocular diseases.
2. Patient have allergic to Drugs.
3. Recently operated eye below 1 month.
4. Patient having systemic Disease likes DM.
5. Congenital anomalies of eye. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Karanjadi Rasakriya Anjana is effective in management of Klinnavartma |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dhatryanjana is effective in mamagement of Klinnavartma |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="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
|
|
According to Ayurved
Urdhvanga means Shalakya Tantra which is one of the most important and
finest branch of Ashtang Ayurved. In Sushrut Samhita, Acharya Sushrut Explained
Netra Rachana, Netragat Vyadhi and its Chikitsa in Uttartantra.
Klinnavartma is one among the 76
Netraroga’s explained by Aacharya
Sushrut Klinnavartma is a Vartmagat Netrarog mentioned
by Aacharya Sushrut as sadhya vyadhi . In Ayurveda, Klinnavartma refers to a
specific eye disease characterized by excessive watering and discharge from
the eyes. This condition is often linked to an imbalance in the doshas,
particularly an excess of Kapha. Symptom of Klinnavartma can includes state
of excessive moisture ,Itching ,pricking pain, discharge.
In modern science,
Klinnavartma can be correlated with Ulcerative blepharitis, a common
inflammatory condition of the eyelids. Both conditions involve similar symptoms.The term Blepharitis consists of two words
’Blepharon’ (a Greek word) means eyelid and -itis means inflammation. Bacterial blepharitis,
also known as chronic anterior blepharitis, or staphylococcal blepharitis or
ulcerative blepharitis, is a chronic infection of the anterior part of the
lid margin. In the Sushrut Samhita, Dalhan explains
that "Klinnavartma," also referred to as "Pilla" . Acharya vaghbhat describe the treatment of
pilla roga, in this he used Karanjadi Rasakriya Anjana.
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