| CTRI Number |
CTRI/2025/04/085166 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Saindhavaadi Bidalaka And Yashtigairikaadi Bidalaka In The Management of Klinnavartma w.s.r. to Blepharitis |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Saindhavaadi Bidalaka And Yashtigairikaadi Bidalaka In The Management Of Klinnavartma w.s.r. to 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 Bhavya Singh Rana |
| Designation |
PG Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre, Bhopal, MADHYA PRADESH |
| Address |
Fourth Floor Room No. 2, Department Of Shalakya Tantra, Mansarovar Ayurvedic Medical College Hospital and Research Centre, Bhopal, MADHYA PRADESH 462042 India
Bhopal
MADHYA PRADESH
462042
India
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7987280998 |
| Fax |
|
| Email |
drbhavyasrana82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Lohakare |
| Designation |
Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre, Bhopal, MADHYA PRADESH |
| Address |
Fourth Floor Room No. 2, Department Of Shalakya Tantra, Mansarovar Ayurvedic Medical College Hospital and Research Centre, Bhopal, MADHYA PRADESH 462042 India
Bhopal
MADHYA PRADESH
462042
India
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9890698452 |
| Fax |
|
| Email |
shindeshubh84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavya Singh Rana |
| Designation |
PG Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre, Bhopal, MADHYA PRADESH |
| Address |
Fourth Floor Room No. 2, Department Of Shalakya Tantra, Mansarovar Ayurvedic Medical College Hospital and Research Centre, Bhopal, MADHYA PRADESH 462042 India
Bhopal
MADHYA PRADESH
462042
India
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7987280998 |
| Fax |
|
| Email |
drbhavyasrana82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar Ayurvedic Medical College Hospital and Research Centre, Bhopal |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Fourth Floor Room no. 2, Department of Shalakya Tantra, Mansarovar Ayurvedic Medical College Hospital and Research Centre, Hinotiya Alam, Kolar Road, Bhopal, MADHYA PRADESH |
| 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 |
| Dr Bhavya Singh Rana |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
Fourth Floor Room No. 2, Department of Shalakya Tantra, Mansarovar Ayurvedic Medical College Hospital and Research Centre, Bhopal, MADHYA PRADESH
462042
India
Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH |
7987380998
drbhavyasrana82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mansarovar Ayurvedic Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H010||Blepharitis. Ayurveda Condition: PRAKLINNAVARTMA/KAPOTKLISHTA-VARTMA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | biDAlaka:, बिडालक: | (Procedure Reference: Chakra Dutt, Procedure details: A lukewarm paste will be applied on the outer skin around the eyes, excluding the eyelashes.)
(1) Medicine Name: Saindhavaadi Bidalaka, Reference: Chakra Dutt, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | biDAlaka:, बिडालक: | (Procedure Reference: Sharangdhar Samhita, Procedure details: A lukewarm paste will be applied on the outer skin around the eyes, excluding the eyelashes.)
(1) Medicine Name: Yashtigairikaadi Bidalaka, Reference: Sharangdhar Samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient having signs and symptoms of Klinnavartma w.s.r. to Blepharitis. |
|
| ExclusionCriteria |
| Details |
Age below 18 years and above 70 years.
Traumatic Eye Injury and recent Eye Surgery.
Chronic infections and Ocular Allergies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Saindhavaadi Bidalaka and Yashtigairikaadi Bidalaka in Klinnavartma |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study Klinnavartma and Blepharitis and to study the mode of action of Saindhavaadi Bidalaka and Yashtigairikaadi Bidalaka |
7 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/04/2025 |
| 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="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
|
Total 60 patients will be randomly selected and divided into 2 groups. One group will be treated with Saindhavaadi Bidalaka, second group will be treated with Yashtigairikaadi Bidalaka in the management of Klinnavartma w.s.r. to Blepharitis. To study deeply about Blepharitis according to modern science and Klinnavartma according to Samhitas. Klinnavartma is a condition affecting the eyelid, making local application a suitable treatment approach. |