CTRI Number |
CTRI/2016/02/006582 [Registered on: 01/02/2016] Trial Registered Retrospectively |
Last Modified On: |
29/01/2016 |
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 Glaucoma(primary open angle glaucoma) |
Scientific Title of Study
|
CLINICAL STUDY ON Primary Open Angle Glaucoma WITH aschyotana,tarpana & oral medication |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR SHWETA AGRAWAL |
Designation |
RESEARCH SCHOLAR |
Affiliation |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR |
Address |
DEPARTMENT OF SHALAKYA TANTRA,IPGT AND RA,GAU JAMNAGAR DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U.
JAMNAGAR Jamnagar GUJARAT 361008 India |
Phone |
8690255129 |
Fax |
|
Email |
dr.shwetaagrawal2@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Majusha Rajgopala |
Designation |
PROFESSOR |
Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
Address |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U.
JAMNAGAR DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U.
JAMNAGAR Jamnagar GUJARAT 361008 India |
Phone |
9428400759 |
Fax |
|
Email |
bhatrajma2008@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Majusha Rajgopala |
Designation |
PROFESSOR |
Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
Address |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U.
JAMNAGAR DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U.
JAMNAGAR Jamnagar GUJARAT 361008 India |
Phone |
9428400759 |
Fax |
|
Email |
bhatrajma2008@gmail.com |
|
Source of Monetary or Material Support
|
Institute for Post Graduate Teaching and Research in Ayurveda Gujrat
Ayurved University Jamnagar361008 |
|
Primary Sponsor
|
Name |
IPGT AND RA GAU |
Address |
IPGT AND RA GAU JAMNAGAR |
Type of Sponsor |
Research institution and hospital |
|
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 SHWETA AGRAWAL |
DEPT. OF SHALAKYA TANTRA |
OPD no.4
Institute for Post
Graduate
Teaching and
Research in
Ayurveda Gujrat
Ayurved
University 361008 Jamnagar GUJARAT |
8690255129
dr.shwetaagrawal2@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Institutional Ethics Committee IPGT and RA Jamnaga |
Approved |
Institutional Ethics Committee IPGT and RA Jamnagar |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
PATIENTS HAVING PRIMARY OPEN ANGLE GLAUCOMA, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group A |
Tarpana with Shigru pallava arka,
Punarnavashtaka Kwath,
Gokshuradi Guggulu,
Shigru Pallava Arka eye drops,
Timolol (0.5 %) |
Comparator Agent |
Group B |
Group B (Control Group)-
In this group patients already taking Betaxolol 0.5 % or Timolol 0.5 %, topical anti Glaucoma (IOP lowering) treatment will be kept under observation as a control group.
Total duration: 52 Days
|
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
•Patients of POAG having IOP < 21mmHg (Normal Tensive Glaucoma) and IOP > 21 mmHg.
•Visual acuity > 6/60 and clear media.
|
|
ExclusionCriteria |
Details |
•All types of PACG will be excluded.
•Secondary and developmental Glaucoma including exfoliative Glaucoma, pigmentary Glaucoma, trauma induced, inflammatory Glaucoma.
•POAG with advanced stage of optic atrophy.
•Visual acuity < 6/60.
• All types of cataract will be excluded.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1.To propound the concept of chakshushya, rasayana, & diuretic therapy in the management of POAG.
2.To evaluate the Neuroprotective effect of Ayurvedic line of management in POAG.
|
52 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
To assess the role of Ayurvedic line of management in lowering IOP. |
52 |
|
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" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
27/02/2015 |
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) |
Open to Recruitment |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Glaucoma is the second leading cause of irreversible
vision loss in the world, responsible for approximately 15% of blindness worldwide,
and it is estimated that 6.7 million of the 67 million people affected by
Glaucoma worldwide are bilaterally blind (Quingley1996)1.Glaucoma
is not a single disease process but a group of disorders characterized by a progressive
optic neuropathy resulting in a characteristic appearance of the optic disc and
a specific pattern of irreversible visual field defects that are associated
frequently but not invariably with raised intraocular pressure.2Several
variants of Glaucoma exist, classified according to their etiology (i.e. congenital, primary or
secondary), but the main types are Primary Open Angle Glaucoma (POAG) and
Primary Angle Closure Glaucoma (PACG).POAG is the most common type of Glaucoma. Management
of some of the ophthalmic condition is challenging to ophthalmologist till
today, POAG is one among them.The
current strategy of modern management of Glaucoma is mainly concentrated on
lowering intra ocular pressure. A wide range of tropical & systemic anti-
glaucoma medication is available in modern science such as-β-blockers, α-agonist,
miotics, prostaglandin analogs etc. and the surgical procedures include-Trabeculotomy
and other fistulizing anti-glaucoma surgeries. As the known medical as well as
surgical procedures have their own limitations and side effects, no doubt these
procedures bring down some of the symptoms but at the same time create one or
the other problem.
Therefore
it was felt necessary that the herbal treatment should be tried as an effective
therapy with minimum hazards.Ayurveda already have a concept
of chakshushya drugs which may have
neuroprotective and immuno-modulatory property which may check the Glaucomatous
Optic Neuropathy (GON). In Patients of raised intra ocular tension Diuresis is
one of the mechanism to reduce it. The combination like Punarnavashtaka Kwath &
Gokshuradi Guggulu contains drugs
having many properties such as- Mootra
virechaka (Diuretic), Shothahara(Anti-inflammatory),Rasayana(Immuno-modulatory),Vatanadibalya (Neuroprotector), Chakshushya (eye tonic) etc. In ophthalmic
O.P.D. these combination have been used with encouraging results hence it was
decided to select these two drugs internally for the present study.
Shigru pallava arka
as in Tarpana & Aschyotana (eye drops) are being used by
ophthalmic practitioners on Glaucoma patients and they report good results but
scientific data is not reported. By virtue of its srotoshodhaka property it might be useful in relieving the symptoms
of POAG. Safety profile of Shigru pallava
arka will be done first before
starting the Tarpana treatment on
patients. Hence it is decided
to evaluate the efficacy of Punarnavashtaka
Kwath & Gokshuradi Guggulu
orally and Shigru pallava arka
locally. Before starting the treatment Kostha
shodhana will be done for 3 days by erandbhristhaharitaki
and Nasya with Anu taila for 7 days will be done. GROUPING
The selected patients will be randomly divided into
two groups: Group A (Trial group) and Group B (Control group).There will be 15
patients in each group. CRITERIA FOR ASSESSMENT Subjective Parameters: Objective Parameters: ·
Visual Acuity using snellens chart ·
Schiotz or Applanation Tonometry ·
Direct and indirect ophthalmoscopic
examination ·
Fundus Photography ·
Automated perimetry (Base line, after 2
month) ·
OCT (if possible) to evaluate optic disc,
optic cup.
Statistical test:
‘t’ test will be applied for
calculating significance of the treatment. |