| CTRI Number |
CTRI/2025/03/081797 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on efficacy of Saindhavadi Bidalaka in the management of Vataj Abhishyanda with special reference to allergic conjunctivitis |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of Saindhavadi Bidalaka in the management of Vataj Abhishyanda with special reference to allergic conjunctivitis |
| 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 MANJU LALCHAND YADAV |
| Designation |
PG SCHOLAR |
| Affiliation |
LRP Ayurvedic medical college and hospital,PG institute and research centre |
| Address |
LRP Ayurvedic medical college and hospital,PG institute and research centre,urun islampur,shalakyatantra department,OPD 11,Sangli,Maharashtra,415409, INDIA
Sangli
MAHARASHTRA
415409
India |
| Phone |
8623896934 |
| Fax |
|
| Email |
manjuy946@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Walvekar |
| Designation |
Reader |
| Affiliation |
LRP Ayurvedic medical college and hospital,PG institute and research centre |
| Address |
LRP Ayurvedic medical college and hospital,PG institute and research centre,urun islampur,shalakyatantra department,OPD 11,Sangli,Maharashtra,415409,INDIA
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822442719 |
| Fax |
|
| Email |
sunilwalvekar99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANJU LALCHAND YADAV |
| Designation |
PG SCHOLAR |
| Affiliation |
LRP Ayurvedic medical college and hospital,PG institute and research centre |
| Address |
LRP Ayurvedic medical college and hospital,PG institute and research centre,urun islampur,shalakyatantra department,OPD 11,Sangli,Maharashtra,415409, INDIA
Sangli
MAHARASHTRA
415409
India |
| Phone |
8623896934 |
| Fax |
|
| Email |
manjuy946@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic medical college and hospital,PG institute and research centre, Urun islampur, 415409 |
|
|
Primary Sponsor
|
| Name |
DR MANJU LALCHAND YADAV |
| Address |
LRP Ayurvedic medical college and hospital,PG institute and research centre,urun islampur 415409 |
| 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 MANJU LALCHAND YADAV |
LRP ayurvedic medical college and hospital ,PG institute and Research centre urun islampur |
LRP Ayurvedic medical college and hospital,PG institute and research centre,urun islampur,shalakyatantra department,OPD 11,Sangli,Maharashtra,415409, INDIA
Sangli
MAHARASHTRA |
08623896934
manjuy946@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC LRP Ayurvedic medical college and hospital,PG institute and research centre, Urun islampur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: ABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SAINDHAVADI BIDALAKA , Reference: VAGBHATA , Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Thickness 1/4 th of anguli pramana |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.patients showing the classical sign and symptoms of allergic Conjunctivitis will be selected for the study.
2.Patients who are between the ages of 15yr&50yr will be selected for the study
3.Patients irrespective of sex, occupation and socio-economic status will be selected. |
|
| ExclusionCriteria |
| Details |
1.Patients older than 50 yrs&younger than 10 yrs
2.Patients who have another eye condition
3.Patients who recently had eye surgery
4.Patients with other major systemic diseases
5.Taking any other eye medications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Saindhavadi Bidalaka in the management of Vataj Abhishyanda |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the detail literature about Vataj Abhishyanda
2.To Study the detail literature about Allergic Conjunctivitis
3.To study the effect of Saindhavadi Bidalaka in vataj Abhishyanda with special reference to Allergic Conjunctivitis |
7-28 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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
|
Aims:To study efficacy of Saindhavadi Bidalaka in Vataj Abhishyanda with special reference to Allergic Conjunctivitis.Objective:- PRIMARY OBJECTIVE : To study the efficacy of Saindhavadi Bidalaka in the management of Vataj Abhishyanda. SECONDARY OBJECTIVE : 1. To study the detail literature about Vataj Abhishyanda. 2. To study the detail literature about Allergic Conjunctivitis. 3. To study the effect of Saindhavadi Bidalaka in Vataj Abhishyanda with special to allergic conjunctivitis
Type of study design :Single Arm clinical study
Study setting : Patient coming in shalakya opd
Study population All the diagnosed cases of vataj abhishyanda in our ayurved hospital Opd Study duration : Duration of entire study : 18 months Duration of treatment : 7 days Follow up : 14 th, 28 th day Diagnostic criteria : Patient will be diagnosed on the basis of clinical sign
Assessment criteria : Subjective parameter are based on symptomatic relief i.e nistoda, kandu, photophobia
The data obtained will be analyzed statistically.
Observation and Results: The observed Clinical Efficacy of treatment will be observed and recorded.
Discussion: Results will have discussed on the basis of collected data and statistical analysis.
Conclusion: It will be drawn strictly on the basis of statistical analysis.
Summary: The research study will be summarized in brief.
Ethical Consideration: The study will be conducted in accordance with ethical guidelines and inform consent from participant.
|