| CTRI Number |
CTRI/2024/07/069864 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Using a combination of herbal medicine like Yashtyadi Kwatha Netra dhara and Rajanyadi Choorna internally can help treat Mild to Moderate Allergic Conjunctivitis |
|
Scientific Title of Study
|
Combined effect of Yashtyadi Kwatha Seka and Rajanyadi Chorrna internally in Mild to Moderate 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 |
Krishnapriya A P |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Kannur Pariyaram |
| Address |
Department of Shalakyatantra
Government Ayurveda College Kannur Pariyaram
Kannur
KERALA
670503
India |
| Phone |
7561098813 |
| Fax |
|
| Email |
krishnapriyaap2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ambili K |
| Designation |
Associate professor |
| Affiliation |
Government Ayurveda College Kannur Pariyaram |
| Address |
Department of Shalakyatantra
Government Ayurveda College Kannur
Government Ayurveda College Kannur Pariyaram
Kannur
KERALA
670503
India |
| Phone |
09446028794 |
| Fax |
|
| Email |
amlikavinal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishnapriya A P |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Kannur Pariyaram |
| Address |
Department of Shalakyatantra
Government Ayurveda College Kannur Pariyaram
Government Ayurveda College Kannur Pariyaram
Kannur
KERALA
670503
India |
| Phone |
7561098813 |
| Fax |
|
| Email |
krishnapriyaap2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Kannur Pariyaram |
|
|
Primary Sponsor
|
| Name |
Krishnapriya A P |
| Address |
Department of Shalakyatantra
Government Ayurveda College Kannur Pariyaram
Government Ayurveda College Kannur Pariyaram |
| 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 Krishnapriya AP |
Government Ayurveda College Kannur Pariyaram |
OP no 8
Department of Shalakyatantra
Government Ayurveda College Kannur Pariyaram
Kannur
KERALA |
7561098813
krishnapriyaap2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurveda College Kannur Pariyaram |
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 | Procedure | - | sekaH, सेकः | (Procedure Reference: SARANGADHARA SAMHITA, Procedure details: POORVAKARMA
Yashtyadi kwatha will be prepared and filtered through a clean cloth so that there will not be
any minute particles in it. The procedure will be well explained to the research participant.
9
PRADHANAKARMA
The research participant will be made to lie down on the treatment table in supine position.
Face and eyes will be cleaned with cotton. A piece of cotton plug will be placed in both ears so
that any portion of medicine will not be entered into ears. Participant will ask to close the eyes.
Medicated decoction in the prescribed quantity will be taken in a neti pot and poured through
a pichuvarti from a height of 4 angulas12
in a thin, slow and continuous stream over the closed
lids from medial to lateral canthus. Procedure will be done for 2 minutes.
PASCHATKARMA
Eyes will be cleaned with soft cotton cloth to wipe off remaining medicines.)
(1) Medicine Name: RAJANYADI CHOORNA, Reference: ASHTANGA HRUDAYA UTTARAM, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Participants between the age group of 10 to 35 years will be selected irrespective of gender
Participants fulfilling one or more features in the diagnostic criteria of mild to moderate
allergic conjunctivitis
Participants presenting with TOSS Score symptoms and objective signs |
|
| ExclusionCriteria |
| Details |
Participants with chronic allergic conjunctivitis
Known cases dyslipidemia and glaucoma
Participants who have undergone eye surgery within last 6 months and suffering from corneal pathology ocular injuries and suspected foreign body in the eye
Participants taking anti allergic medication and also using any kind of eye drops
Pregnant ladies and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Itching
Redness
Watering of eyes
Edema of lids
Congestion of bulbar and palpebral |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
01/08/2024 |
| 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
|
Allergic conjunctivitis (AC) is a group of diseases affecting the ocular surface that is associated with hypersensitivity reactions. Allergic reactions in the conjunctiva can produce irritating and annoying ocular signs & symptoms like itching, watering, redness, and some papillae changes. In the present study, an attempt has been made to scientifically prove the effect of Yashtyadi kwatha seka and Rajanyadi choorna internally in mild to moderate allergic conjunctivitis.The null hypothesis is the combination of yashtyadi kwatha seka and rajanyadi choorna has no effect in mild to moderate allergic conjunctivitis.alternate hypothesis is the combination of yashtyadi kwatha seka and rajanyadi choorna has an effect in mild to moderate allergic conjunctivitis.The study will be conducted as pre and post interventional clinical trial in 26 participants in the age group of 10-35 years with clinical features of mild to moderate allergic conjunctivitis. The participants will be selected from the Outpatient Department of Shalakyatantra, fulfilling the inclusion criteria.Data collection will be done using case proforma and clinical examinations, which include symptomatic scoring using TOSS (Total Ocular Symptom Score) and objective criteria numerical scoring. The outcome will be graded using subjective and objective parameters. The obtained data will be statistically analyzed. |