| CTRI Number |
CTRI/2023/04/051677 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
22/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Effect Of Shigru-Haridradi Aschyotana (Eye Drop) with Haridrakhanda and Bilvadi Aschyotana with Haridrakhanda in Vataja Abhishyanda(Simple Allergic Conjunctivitis). |
|
Scientific Title of Study
|
Efficacy Of Shigru-Haridradi Aschyotana (Eye Drop) with Haridrakhanda and Bilvadi Aschyotana with Haridrakhanda in the Management of Vataja Abhishyanda (Simple Allergic Conjunctivitis) - An Open Labelled Randomized Comparative Clinical Trial. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratiksha Virwal |
| Designation |
MS Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
4th floor Department of Shalakyatantra Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar,
Gujarat
GUJARAT
Opd no.3, Shalakyatantra department, Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar,
Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
7023230244 |
| Fax |
|
| Email |
Pratikshavirwal7504@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Pawar |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
4th floor Department of Shalakyatantra Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar,
Gujarat
Opd no.3 Shalakyatantra department,Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar,
Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
7737379173 |
| Fax |
|
| Email |
drpawar29@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Pawar |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
4th floor Department of Shalakyatantra Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar,
Gujarat
Opd no.3, Department of Shalakatantra Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar,
Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
7737379173 |
| Fax |
|
| Email |
drpawar29@itra.edu.in |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar,
Gujarat,361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
4th floor Department of Shalakyatantra Institute of Teaching and Research in Ayurveda Opposite Relince Mart near B division city police station Jamnagar
Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pratiksha Virwal |
Opd no.3, Department of Shalakyatantra, ITRA Hospital Jamnagar Gujarat |
4th Floor department of Shalakatantra, Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar,
Gujarat,361008
Jamnagar
GUJARAT |
7023230244
pratikshavirwal7504@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H109||Unspecified conjunctivitis. Ayurveda Condition: SARVAGATAKSHIROGAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | AScyotanam, आशà¥à¤šà¥à¤¯à¥‹à¤¤à¤¨à¤®à¥ | (Procedure Reference: Kaviraj Atrideva Gupta, Astanga Samgraha of Acharya Vagbhatta, Sutra sthan 32/4, reprinted edition (2016), Chaukhamba Krishnadas Academy Publisher, pg. 226, Procedure details: • The patient should ask to lie down in supine / semi supine position.
• Patient’s eyes should be clean using wet cotton.
• The eye is opened by one hand and instillation of 2 drops Luke warm Bilvadi Aschyotana with another hand will be done with the measuring dropper from 3-4cm height to Kaninika Sandhi (Inner canthus area) in each eye.
• Then ask patient to rotate his/her eyes and after 1 minute install another 2 drops. In this manner total dose of 0.5ml per day for one eye should)
(1) Medicine Name: Shigru-Haridradi Aschyotana (Eye drop), Reference: Anubhuta, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: tds, Duration: 2 Weeks | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haridrakhanda, Reference: Shri Govind Das, Bhaishajya Ratnavali, 55/13-17, Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: -lukewarm Milk), Additional Information: - | | 3 | Comparator Arm | Procedure | - | AScyotanam, आशà¥à¤šà¥à¤¯à¥‹à¤¤à¤¨à¤®à¥ | (Procedure Reference: Kaviraj Atrideva Gupta, Astanga Samgraha of Acharya Vagbhatta, Sutra sthan 32/4, reprinted edition (2016), Chaukhamba Krishnadas Academy Publisher, pg. 226, Procedure details: • The patient should ask to lie down in supine / semi supine position.
• Patient’s eyes should be clean using wet cotton.
• The eye is opened by one hand and instillation of 2 drops Luke warm Bilvadi Aschyotana with another hand will be done with the measuring dropper from 3-4cm height to Kaninika Sandhi (Inner canthus area) in each eye.
• Then ask patient to rotate his/her eyes and after 1 minute install another 2 drops. In this manner total dose of 0.5ml per day for one eye should)
(1) Medicine Name: Bilvadi Aschyotana, Reference: Chakradatta, Netraroga Chikitsa Prakarana, 59/13, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(drops), Frequency: tds, Duration: 2 Weeks | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridrakhanda, Reference: Shri Govind Das, Bhaishajya Ratnavali, 55/13-17, Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: -lukewarm milk), Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between 18 to 50 years of age.
2. Patients having minimum three symptoms of Simple Allergic Conjunctivitis.
|
|
| ExclusionCriteria |
| Details |
1. Patients below 18 years and above 50 years of age.
2. Patients having complications of corneal involvement like Marginal Corneal Ulcer, Dacryocystitis, Trachoma, Keratoconjunctivitis sicca, Vernal Keratoconjunctivitis, Giant papillary conjunctivitis, Atopic Keratoconjunctivitis.
3. All types of Conjunctivitis (Acute and Chronic) which are non-allergic in nature are excluded from the Study.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Relief in Subjective and Objective Criteria of Vataja Abhishyanda (Simple Allergic Conjunctivitis). |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in Subjective and Objective Criteria of Vataja Abhishyanda (Simple Allergic Conjunctivitis). |
4-6weeks |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2023 |
| 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
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Introduction:Conjunctival hyperemia or Conjunctivitis (inflammation of outermost layer of the eye and innermost layer of the eyelids) is the commonest eye disorder nowadays and among them Ocular allergy represents one of the most common conditions encountered by allergists and ophthalmologists. It has an equal distribution throughout the world, without any exception to the developed and under developed countries. It is categorized as infective and non-infective conjunctivitis. Simple Allergic Conjunctivitis is a non-infective type of conjunctivitis in which inflammation of conjunctiva occurs due to allergic or hypersensitive reactions by dust, pollen, air pollution and other environmental factor which may be immediate or delayed.Significance:Prevalence rate of Simple Allergic Conjunctivitis is 10% to 30% of the general population,Recurrence in 41-62% cases have an equal distribution throughout the world, without any exception to the developed and under developed countries.In the management of Simple Allergic Conjunctivitis most of the drugs are Anti-allergic and Immune-modulators areused. But both have temporary effects and high recurrence rate.So, to prove the efficacy there is need of Ayurvedic interventions like Aschyotana (Eye drop) therapy (alternative medicine) and Ayurvedic Anti-allergic oral medication which is devoid of side effects and reduce the recurrence rate of Vataja Abhishyanda (Simple Allergic Conjunctivitis).Materials and Methods:Minimum 30 patients will be enrolled on the basis of symptoms of Pricking Pain (Nistoda), Foreign body sensation (Sangharsh), Redness (Ragata), Dryness- Feeling (Vishushka Bhava), Clean /Watery discharge (Achchasruta), Mild Chemosis (Alpa Shopha) , Itching (Kandu), Burning sensation(Daha).Group A Patients will receive Shigru-Haridradi Aschyotana (Eye drop) along with Haridrakhanda and Group B Patients will receive Bilvadi Aschyotana along with Haridrakhanda .Results and Discussion:Data generated during the above study will be presented in a systematic manner and shall be analysed statistically. Follow up:After completion of therapy, follow up will be done for 2 weeks to assess the status of patient, where patient will be asked to report fortnightly.Adverse effects: this proposal will be reviewed and approved by I.T.R.A. Institutional Ethical Committee , Which is having the responsibility to protect the research participants from harm. These drugs have no known unwanted effects . it is possible that it may also cause some problems that we are not aware of. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A. |