| CTRI Number |
CTRI/2024/03/064625 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Rasanjanadi Anjana in
Seasonal Allergic Conjunctivitis |
|
Scientific Title of Study
|
Efficacy and Safety of an Ayurvedic Ophthalmic
Ointment (Rasanjanadi Anjana) in the Treatment of
Seasonal 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)
Modification(s)
|
| Name |
Dr Palash Agrawal |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India |
| Address |
Department of Shalakya Tantra, Government Ayurvedic college and hospital, Kadamkuan, Patna, Bihar, India
Patna
BIHAR
800003
India |
| Phone |
8770071015 |
| Fax |
|
| Email |
palashagrawal6897@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Prof Kumari Uma Pandey |
| Designation |
Professor and HOD of Shalakya Tantra Department |
| Affiliation |
Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India |
| Address |
Department of Shalakya Tantra, OPD Room No. 2, Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India
Patna
BIHAR
800003
India |
| Phone |
9431646285 |
| Fax |
|
| Email |
umapandey.nipun@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Prof Kumari Uma Pandey |
| Designation |
Professor and HOD of Shalakya Tantra Department |
| Affiliation |
Government Ayurvedic College and Hospital Patna, Bihar, India |
| Address |
Department of Shalakya Tantra, Government Ayurvedic college and hospital, Kadamkuan, Patna, Bihar, India
Patna
BIHAR
800003
India |
| Phone |
9431646285 |
| Fax |
|
| Email |
umapandey.nipun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakya tantra, Government Ayurvedic college & Hospital, Kadamkuan, Patna-3,
Bihar, India |
|
|
Primary Sponsor
|
| Name |
Dr Palash Agrawal |
| Address |
Department of Shalakya Tantra, OPD - Room No.3, Goverment Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India |
| 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 Palash Agrawal |
Government Ayurvrdic College & Hospital, Kadamkuan, Patna, Bihar, India |
OPD-Room No.3
(Ground floor), IPD (Second floor)
Department of
Shalakya Tantra,
Government Ayurvedic
College & Hospital,
Kadamkuan, Patna-3
Patna
BIHAR |
8819037292
palashagrawal6897@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurvedic College Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H101||Acute atopic conjunctivitis. Ayurveda Condition: ABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Loteprednol etabonate ophthalmic ointment 0.5% | Loteprednol etabonate ophthalmic ointment 0.5% – twice a day for 4 weeks | | 2 | Intervention Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: अषà¥à¤Ÿà¤¾à¤™à¥à¤—हृदय उतà¥à¤¤à¤°à¤¸à¥à¤¥à¤¾à¤¨ १६/५२-५३, Procedure details: Rasanjanadi Anjana – twice a day for 4 weeks. )
(1) Medicine Name: Rasanjanadi Anjana, Reference: अषà¥à¤Ÿà¤¾à¤™à¥à¤—हृदय उतà¥à¤¤à¤°à¤¸à¥à¤¥à¤¾à¤¨ १६/५२-५३, Route: Ocular, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(NA), Frequency: bd, Duration: 4 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will meet the following criteria will be selected for the study.
a) Patients of either gender aged 12 years or older and suffering from SAC, will be diagnosed on the basis of their history, the presence of moderate to severe ocular itching, and at least one of the following bilateral signs and symptoms of at least moderate severity: conjunctival hyperaemia, conjunctival chemosis, eyelid swelling, or tearing.
b) Patients able to maintain a diary.
c) Patients able and willing to provide written informed consent.
d) No expectation that subject will be moving out of the area of the study center during the study period.
|
|
| ExclusionCriteria |
| Details |
a) Patients with any other form of allergic conjunctivitis.
b) Patients with bacterial, chlamydial, viral, giant papillary, phlyctenular, purulent, and membranous conjunctivitis.
c) The presence of dry eye syndrome, blepharitis, uveitis, keratitis, and ocular trauma.
d) Patients with a history of ocular surgery performed in the last 3 months.
e) Patients who had systemic or ocular corticosteroids in the last 3 months, mast cell stabilizers within 2 weeks of randomization, or any other ophthalmic medication within 3 days of randomization.
f) Patients with retinal detachment, diabetic retinopathy, and progressive retinal disease.
g) Pregnant and lactating women.
h) Patients with a history of hypersensitivity to any of the study medications.
i) Active participation in any type of intervention study.
j) Patients who start developing complications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in responder rate as judged by subjects about the overall effect of treatment on symptoms using a five-point grading scale at the follow-up and end visit compared with baseline. |
day 7, day 15, day 21, day 30, and day 45. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean change in investigator assessment score (overall effect of treatment on signs & symptoms) at the follow-up & end visit compared with baseline.
2. Mean change in the severity of individual & composite scores of ocular symptoms (itching, tearing) & signs (redness, eyelid swelling, chemosis, papillae) after 4 weeks of treatment compared with baseline.
3. The tolerability & safety of Ayurvedic intervention (Rasanjanadi Anjana). |
day 7, day 15, day 21, day 30, & day 45. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
02/04/2024 |
| 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
|
Purpose: To assess the effects of an
Ayurvedic ophthalmic ointment (Rasanjanadi Anjana) in the
treatment of Seasonal Allergic Conjunctivitis (SAC) compared to Loteprednol
etabonate ophthalmic ointment 0.5%.
Design: Clinical, Prospective,
Randomized, Open labelled, Parallel Group, Drug controlled, Single
blind study.
Participants: (n=20) Patients of
either gender aged 12 years or older and suffering from SAC, will be diagnosed
on the basis of their history, the presence of moderate to severe ocular
itching, and at least one of the following bilateral signs and symptoms of at
least moderate severity: conjunctival hyperaemia, conjunctival chemosis, eyelid
swelling, or tearing.
Methods: Patients will be
randomized in a 1:1 ratio to study treatment with trial drug (Rasanjanadi
Anjana) or Control drug (Loteprednol etabonate ophthalmic ointment 0.5%).
Patients will be followed for 6 weeks at 5 scheduled visits (day 7, day 15, day
21, day 30, and day 45.). At each visit, ocular symptoms (itching, tearing)
will be graded by the subject, and ocular signs (redness, eyelid swelling,
chemosis) will be graded by the investigator, using ordinal grading scales. Subjects
will be asked to assess the overall effect of treatment on symptoms using a
five-point grading scale at the follow-up visits. In addition to individual
scores, the composite scores for ocular signs and symptoms will be calculated.
Main
outcome measures: Primary
efficacy outcome will be mean change in responder rate as judged by subjects
about the overall effect of treatment on symptoms using a five-point grading
scale at the follow-up and end visit compared with baseline. Secondary efficacy
outcome will be mean change in investigator assessment score (overall effect of
treatment on signs and symptoms) at the follow-up and end visit compared with
baseline. Also the mean change in the severity of individual and composite
scores of ocular symptoms (itching, tearing) and signs (redness, eyelid
swelling, chemosis, papillae) after 4 weeks of treatment compared with
baseline. The tolerability and safety of Ayurvedic intervention (Rasanjanadi
Anjana) will also be assessed.
Results: Both groups will be
compared on the basis of main outcome measures. |