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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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:

  • Blurred vision
  • Delayed dark adaptation

          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:       â€˜t’ test will be applied for calculating significance of the treatment.

 
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