| CTRI Number |
CTRI/2024/11/076491 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Punarnava Arka preparation and clinical trial in Allergic conjuntivitis |
|
Scientific Title of Study
|
Evaluate the effect of punarnava arka in simple allergic conjunctivitis - a randomised controlled clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BMK/23/PG/SKT/04 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahore Akash Manohar |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya, Shahapur, BELAGAVI, Karnataka, INDIA |
| Address |
Department of Shalakyatantra (Opd no 27) KAHERs Shri BMK
Ayurveda Mahavidyalaya, Shahapur, 590003, BELAGAVI, KARNATAKA
India
Belgaum
KARNATAKA
590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9130165010 |
| Fax |
|
| Email |
akashmahore111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arunkumar B Biradar |
| Designation |
Professor |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya, Shahapur, BELAGAVI, Karnataka, INDIA |
| Address |
Department of Shalakyatantra (Opd no 27) KAHERs Shri BMK
Ayurveda Mahavidyalaya, Shahapur, BELAGAVI, KARNATAKA
590003 India
Belgaum
KARNATAKA
590003
India
Belgaum
KARNATAKA
590003
India |
| Phone |
9964064955 |
| Fax |
|
| Email |
arunkumar.biradar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunkumar B Biradar |
| Designation |
Professor |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya, Shahapur, BELAGAVI, Karnataka, INDIA |
| Address |
Department of Shalakyatantra (Opd no 27) KAHERs Shri BMK
Ayurveda Mahavidyalaya, Shahapur, 590003, BELAGAVI, KARNATAKA, India
Belgaum
KARNATAKA
590003
India |
| Phone |
9964064955 |
| Fax |
|
| Email |
arunkumar.biradar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri BMK Ayurveda Mahavidyalaya, Shahapur, BELAGAVI, 590003, Karnataka, INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Mahore Akash Manohar |
| Address |
KAHERs Shri BMK Ayurveda Mahavidyalaya, Shahapur, BELAGAVI, 590003,
Karnataka, 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 Mahore Akash Manohar |
KAHERs Shri B M Kankanwadi Ayurveda Hospital |
OPD NO 27 KAHERs
Shri BMK Ayurveda
Mahavidyalaya,
Shahapur, BELAGAVI,
Karnataka-590003,
INDIA
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
9130165010
akashmahore111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H109||Unspecified conjunctivitis. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Punarnava, Reference: Dr. Indradev Tripathi, ARKAPRAKASH Of LANKAPATI RAVANA, 1 ST Edition, Varanasi: Krishnadas Academy Oriental Publishers and distributors, 1995 p-52, Route: Topical, Dosage Form: Arka, Dose: 1(drops), Frequency: qid, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: NA, Dosage Form: Arka, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Eyedrop Olopatadine Hydrochloride Ophthalmic Solution | Eye drop olopatadine hydrochloride ophthalmic solution 0.1% is instilled topically 1 drop 2 times a day, intervention period is for 21 days |
|
| Comparator Agent |
Eyedrop Olopatadine Hydrochloride Ophthalmic Solution Ip 0.1 percentage
|
1 Drop 2 times a day Topical
for 21 days
|
| Intervention |
PUNARNAVA ARKA |
1 Drop 6 times a day Topical for 21 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms of Simple Allergic Conjunctivitis and fulfilling the diagnostic criteria |
|
| ExclusionCriteria |
| Details |
Patients suffering from other forms Allergic Conjunctivitis like Keratoconjunctivitis sicca Atopic keratoconjunctivitis Giant papillary conjunctivitis drug or material sensitivity etc
Patients having severe conditions of ocular surface disorders
Patients having complicated eye diseases like Trachoma Trichiasis Steven Johnson syndrome Synechiae etc will be excluded
Patient suffering from bacterial viral chlamydial, parasitic and all other types of conjunctivitis (contagious & non contagious)
Patients suffering from corneal ulcers opacities trauma foreign bodies OSD etc
Conjunctival epitheliopathies like Pterygium Pseudo-pterygium Tumours Retention cysts
Diagnosed cases of Glaucoma retinopathies optic neuritis dry eye and who are under long term topical ocular drug therapies for any ophthalmic infective conditions
Extremely debilitated patients pregnant ladies those who are working with on screen professions
Specific systemic disorders like Renal pathologies Uncontrolled Diabetes Hypertension and Hyperlipidaemia Cardiovascular diseases etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The results of reduction in signs and symptoms
of itching, redness, watering and oedema by Punarnava Arka and Eyedrop Olopatadine Hydrochloride ophthalmic soltion IP 0.1 percent are comparable. |
DAY 0th(Before Treatment)
DAY 21(After Treatment)
DAY 36(Follow Up)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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 Yet Recruiting |
| 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
|
Need for the study : A type 1 hypersensitivity reaction to exogenous allergens in the
atmosphere is simple allergic conjunctivitis. The estimated prevalence is
12.22%. Males are more likely to experience it (13.44%) than females (10.71%).
The most frequent precipitating trigger was dust (35%) and the most common
condition was persistent conjunctivitis (54.8%). There is no known unique aetiology for this moderate,
non-specific inflammation of the conjunctiva, which presents with symptoms of
increased lacrimation, itching, redness, and oedema. Since there is
typically no cure for this illness, care is centred on symptom control and
avoiding situations that exacerbate symptoms. Punarnava is
Shothahara and known for its anti-inflammatory action, Antimicrobial
properties, Analgesic and Antioxidant activities so it
may be brought in practice in the form of Arka. Punarnava arka is selected keeping in view to prove its
efficacy in management of simple allergic conjunctivitis.
Aim :
Effect of PUNARNAVA
ARKA in Simple Allergic Conjunctivitis
Objectives:
To evaluate
the effect of PUNARNAVA ARKA in
Simple Allergic Conjunctivitis
To compare the
effect of Punarnava Arka with control drug.
Research question :
Is Effect of PUNARNAVA
ARKA and Olopatadine Hydrochloride Ophthalmic Solution Ip 0.1% comparable
in the management of simple allergic conjunctivitis? Hypothesis:
H0 – Effect of Punarnava Arka is
not comparable in Simple Allergic Conjunctivitis
H1 – Effect
of Punarnava Arka is comparable in Simple Allergic Conjunctivitis Expected Outcome
–The results of PUNARNAVA ARKA and Eyedrop Olopatadine Hydrochloride Ophthalmic
Solution Ip 0.1% are comparable. |