| CTRI Number |
CTRI/2021/11/037840 [Registered on: 08/11/2021] Trial Registered Prospectively |
| Last Modified On: |
28/10/2021 |
| 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
|
AYURVEDIC MANAGEMENT OF SUB-COJUNCTIVAL HAEMORRHAGE |
|
Scientific Title of Study
|
EFFECT OF KSHOUDRADI ASCHYOTANA IN ARJUNA
w.s.r.t SUB-CONJUNCTIVAL HAEMORRHAGE –A RANDOMISED CONTROLLED CLINICAL TRIAL
|
| Trial Acronym |
KASCH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Adeeb A |
| Designation |
PG SCHOLAR |
| Affiliation |
KAHERSs Shri BM Kankanawadi Ayurveda Mahavidyalaya Belgaum |
| Address |
Department of Shalakyatantra KAHERSs Shri BM
Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India
Belgaum
KARNATAKA
590003
India |
| Phone |
9535861139 |
| Fax |
|
| Email |
adeeba163@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arunkumar Bapurao Biradar |
| Designation |
Associate Professor |
| Affiliation |
KAHERSs Shri BM Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Associate Professor Department of Shalakyatantra KAHERSs Shri
BM Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
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 Bapurao Biradar |
| Designation |
Associate Professor |
| Affiliation |
KAHERSs Shri BM Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Associate Professor Department of Shalakyatantra KAHERSs Shri
BM Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India
Belgaum
KARNATAKA
590003
India |
| Phone |
9964064955 |
| Fax |
|
| Email |
arunkumar.biradar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE ACADEMY OF HIGHER EDUCATION AND RESEARCHES OWNED SHRI B M
KANKANAWADI AYURVEDA MAHAVIDYALAYA AND KLE AYURVEDA HOSPITAL AND
RESEARCH CENTRE SHAHAPUR BELAGAVI
|
|
|
Primary Sponsor
|
| Name |
DR ADEEB A |
| Address |
PG Scholar Department of Shalakyatantra KAHERSs Shri BM
Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 |
| Type of Sponsor |
Other [SELF SPONSORED PG DISSERTATION WORK] |
|
|
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 Adeeb A |
OPD No 27, KLE ayurveda hospital and MRC shahapur belagavi |
KAHERs Shri BM
Kankanawadi Ayurveda
Mahavidyalaya and
Hospital Shahapur
Belagavi
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
9535861139
adeeba163@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:H113||Conjunctival hemorrhage. Ayurveda Condition: ARJUNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kashoudradi aschyotana , Reference: yogaratnakaram, Route: Topical, Dosage Form: Sharkara/ Syrup, Dose: 1(drops), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: 1 drop hourly | | 2 | Comparator Arm (Non Ayurveda) | | - | flurbiprofen eye drops | 1 drop twice a day |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Irrespective of occupation, ocular diseases like refractive error, cataract, squint eyes, chalazion, entropion, ectropion, trichiasis, distichiasis, poliosis.
Idiopathic sub-conjunctival haemorrhages Traumatic sub-conjunctival haemorrhage without epithelial defect
|
|
| ExclusionCriteria |
| Details |
Systemic disorders like DM, HTN, COPD, Renal pathologies
Patients with iatrogenic sub-conjunctival haemorrhage (Post-operative)
Vicarious bleeding associated with menstruation
Patients with other common cause of red eye such as conjunctivitis, episcleritis and scleritis keratitis and corneal ulcer, iritis glaucoma and common condition such as dry eye and blepharitis were excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kshaudraadi Aschyotana if proved effective will help in managing Arjuna (sub conjunctival haemorrhage) |
5days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kshaudradi Aschyotana may be effective in managing arjuna (sub conjunctival haemorrhage |
5 days |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/12/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a randomized controlled clinical study to evaluate the Efficacy of kshaudradi aschyotana in sub conjunctival haemorrhage and to compare with flurbiprofen eye drops for a period of 5 days. Study will be conducted in KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya and Research centre owned KLE Ayurveda Hospital Shahapur BELAGAVI Karnataka India . The expected outcome is to bring down all the symptoms to normalcy |