| CTRI Number |
CTRI/2020/08/027255 [Registered on: 19/08/2020] Trial Registered Prospectively |
| Last Modified On: |
18/06/2021 |
| 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 Treatment for Intra-ocular Hypertension (Glaucoma) |
|
Scientific Title of Study
|
Effect Of Ayurveda Protocol (Nasya, Pindi, Bidalaka, Anjana) In Intraocular Hydrops |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun Das |
| Designation |
PG Scholar |
| Affiliation |
KAHERSs Shri BM Kankanawadi Ayurveda Mahavidyalaya |
| Address |
PG Scholar
Department of Shalakyatantra
KAHERSs Shri BM Kankanawadi Ayurveda Mahavidyalaya
Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9164537685 |
| Fax |
|
| Email |
drarundasayu@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 |
| 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 |
| 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 Arun Das |
| 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 Arun Das |
OPD No 27 |
KAHERs Shri BM Kankanawadi Ayurveda Mahavidyalaya and Hospital Shahapur Belagavi
Belgaum
KARNATAKA |
9164537685
drarundasayu@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: H578||Other specified disorders of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ayurvedic Protocol |
Snaihika Nasya with Ksheerabala 101 X 7 days
Eranda Pindi Bidalaka X 7 days
Gairikadi Anjana X 15 Days |
| Comparator Agent |
Standard AntiGlaucoma Medication |
Timolol Melaetate 0.5% |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
IOP between 22 to 30 mm of Hg(Asymptomatic cases but noticed raised IOP during routine ophthalmic investigations)
Age group 30 to 70years
Irrespective of sex, occupation
Controlled systemic ailments like DM & HTN
Known cases of POAG with existing standard anti-glaucoma medication with Timilol Maleate 0.5% |
|
| ExclusionCriteria |
| Details |
Acute Angle closure glaucoma
IOP ranging above 30mm of Hg
Un-controlled systemic disorders like DM, HTN, COPD, Renal pathologies
End-stage / advanced glaucomatous optic neuropathywith sever visual morbidity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The developed Ayurvedic Protocol may be effective in maanaging IOP at its trget |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The developed protocol may be effective in Preventing complications of ocular hydrops |
45 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)
|
02/11/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 Ayurvedic protocol (Nasya, Pindi Bidalaka and Anjana) in intra ocular hydrops or ocular hypertension and to compare with Standard Anti glaucoma medication (Timolol Melatate 0.5%) for a period of 45 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 the raised IOP to standard target IOP and prevent the consequences resulting out of intraocular hydrops |