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CTRI Number  CTRI/2022/05/042635 [Registered on: 18/05/2022] Trial Registered Prospectively
Last Modified On: 22/07/2022
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   A Clinical Trial to study the Combined Effect of Mahatriphla Ghrita with Ayurvedic Therapy patients with Adhimantha (primary open angle glaucoma)  
Scientific Title of Study
Modification(s)  		 Evaluation of the combined effect of Mahatriphladi Ghrita Nasya, Tarpana, Pana and Rakta-mokshana in Adhimantha (POAG) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dayashankar Singh 
Designation  Associate Professor MS (Ayu) 
Affiliation  Patanjali Bhartiya Ayurvighyan evam Anusandhan Sansthan Haridwar 
Address  O.P.D. NO. 1 Shalakya Department Patanjali Bhartiya Ayurvighyan evam Anusandhan Sansthan Haridwar
O.P.D. NO. 1 Shalakya Department Patanjali Bhartiya Ayurvighyan evam Anusandhan Sansthan Haridwar
Hardwar
UTTARANCHAL
249405
India 
Phone  8194028515  
Fax    
Email  dayaayush@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dayashankar Singh 
Designation  Associate Professor MS (Ayu) 
Affiliation  Patanjali Bhartiya Ayurvighyan evam Anusandhan Sansthan Haridwar 
Address  O.P.D. NO. 1 Shalakya Department Patanjali Bhartiya Ayurvighyan evam Anusandhan Sansthan Haridwar
O.P.D. NO. 1 Shalakya Department Patanjali Bhartiya Ayurvighyan evam Anusandhan Sansthan Haridwar
Hardwar
UTTARANCHAL
249405
India 
Phone  8194028515  
Fax    
Email  dayaayush@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dayashankar Singh 
Designation  Associate Professor MS (Ayu) 
Affiliation  Patanjali Bhartiya Ayurvighyan evam Anusandhan Sansthan Haridwar 
Address  O.P.D. NO. 1 Shalakya Department Patanjali Bhartiya Ayurvighyan evam Anusandhan Sansthan Haridwar
O.P.D. NO. 1 Shalakya Department Patanjali Bhartiya Ayurvighyan evam Anusandhan Sansthan Haridwar
Hardwar
UTTARANCHAL
249405
India 
Phone  8194028515  
Fax    
Email  dayaayush@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Bhartiya Ayurvigyan evam Anusandhana Sansthana Haridwar 
 
Primary Sponsor  
Name  Patanjali Bhartiya Ayurvigyan evam Anusandhana Sansthana Haridwar 
Address  Patanjali Bhartiya Ayurvigyan evam Anusandhana Sansthana Haridwar 
Type of Sponsor  Private medical college 
 
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 
ARCHANA BARTWAL  Patanjali bhartiya ayurvigyan evam anusandhana Sansthana haridwar  Shalakya department (eye), OPD NO 1
Hardwar
UTTARANCHAL 		 9818747297

drarchanabartwal91@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Patanjali Bhartiya Ayurvigyan evam Anusandhana Sansthana Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H401||Open-angle glaucoma. Ayurveda Condition: ADHIMANTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Brimonidine and timololIn this group patients already taking Brimonidine 0.2 % and Timolol 0.5 %, topical anti Glaucoma eye drop.
2Intervention ArmDrugClassical(1) Medicine Name: mahatriphla ghrita, Reference: chakradatta netrarogachikitsa 165-172, Route: Oral, Dosage Form: Ghrita, Dose: 6(ml), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 66 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: mahatriphla ghrita also used in nasya and tarpana for 7 days in 3 sitting.
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age 30 To 70 years
2. Patients of either sex.
3. Patients of POAG having IOP < 21mmHg and IOP > 21 mmHg.
4. Visual acuity more than 6/60 and clear media.
5. Patients of POAG
 
 
ExclusionCriteria 
Details  1.Age below 30 years and above 70 years.
2. Visual acuity less than 6/60
3. Secondary and developmental Glaucoma including exfoliative glaucoma, pigmentary glaucoma,trauma-induced, inflammatory glaucoma, family history of glaucoma
4. Evidence of any anterior segment pathology like conjunctivitis, keratitis, or acute uveitis.
5. History of opaque ocular media (as in cataracts, corneal opacities, vitreous opacities).
6. Pregnant women
7.Any malignancy, uncontrolled diabetes, uncontrolled hypertension.
8.People who are already registered under some other ongoing medical research
9. Contraindicated for Nasya.
10.Contraindicated for Tarpana.
Contraindicated for Rakta-mokshana (jalaukavcharan)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
SUBJECTIVE PARAMETER
1.Blurred vision
2.Frequent change of presbyopic glasses
3.Delayed dark adaptation
4.Visual field defect
5.Headache
 		 for subjective parameter 1st and 90th day
 
 
Secondary Outcome  
Outcome  TimePoints 
OBJECTIVE PARAMETERS: -
1.Visual Acuity using Snellen’s chart
2.IOP using Schiotz or Applanation Tonometry corrected with CCT
3.Direct and indirect ophthalmoscopic examination
4.Automated Perimetry
5. RNFL to evaluate optic disc, optic cup
 		 For objective parameters 1st and 90th day 
 
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
Modification(s)  		 Phase 1/ Phase 2 
Date of First Enrollment (India)   23/05/2022 
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
Modification(s)  		 Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 This study is a randomized, open-labeled, parallel-group, clinical trial, to the evaluation of the combined effect of Mahatriphladi ghrita Nasya, Tarpana, pana and Rakta-mokshana in Adhimantha (POAG). patients of Adhimantha (POAG) will be selected from the OPD/IPD of shalakya department of Patanjali ayurvedic hospital, Haridwar, Uttarakhand and shri krishna eye institute Haridwar. The study will be conducted on a total of 30 patients (15 patients in each group) based on inclusion and exclusion criteria depending on the detailed clinical history, physical examination, and other necessary investigation and irrespective of their gender, caste, or creed. 

 
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