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CTRI Number  CTRI/2023/05/052565 [Registered on: 12/05/2023] Trial Registered Prospectively
Last Modified On: 10/05/2023
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   Efficacy of Ayurvedic Management on Timira with special reference to Simple Myopia 
Scientific Title of Study   Efficacy of Katakaphaladi Varti Anjana and Dashanga Haritaki Modaka orally in the management of Timira with special reference to Simple Myopia- A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shikha Sharma 
Designation  PhD Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Department of Shalakya tantra All India Institute of Ayurveda Mathura road, Sarita Vihar, New Delhi- 110076

New Delhi
DELHI
110076
India 
Phone  9179926994  
Fax    
Email  drshikhasharma04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Narayan Bavalatti  
Designation  Associate Professor 
Affiliation  All India Institute of Ayurveda 
Address  Department of Shalakya tantra All India Institute of Ayurveda Mathura road, Sarita Vihar, New Delhi- 110076

New Delhi
DELHI
110076
India 
Phone  8368105917  
Fax    
Email  eyenimi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shikha Sharma 
Designation  PhD Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Department of Shalakya tantra All India Institute of Ayurveda Mathura road, Sarita Vihar, New Delhi- 110076

New Delhi
DELHI
110076
India 
Phone  9179926994  
Fax    
Email  drshikhasharma04@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Mathura road, Gautampuri, Sarita Vihar, New Delhi-110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda, Mathura road, Gautampuri, Sarita Vihar, New Delhi-110076 
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 
Shikha Sharma  All India Institute of Ayurveda  OPD NO. 110, Shalakya tantra Department, All India Institute of Ayurveda, Mathura road, Gautampuri, Sarita Vihar, New Delhi-110076
New Delhi
DELHI 		 9179926994

drshikhasharma04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-a~jjanam, अंजनम् (Procedure Reference: Tripathi I, Tripathi D. Yogaratnakara with Vidyaprabha Hindi Commentary. Netrarogadhyaya, verse 198-199. 4th ed. Choukhamba Krishnadas Academy. 2013, p.778., Procedure details: Local application (Anjana) from Kaneenaka to Apanga Sandhi-60 mg twice daily morning (6-7 AM) & evening time (6-7 PM) )
(1) Medicine Name: katakaphaladi varti, Reference: Tripathi I, Tripathi D. Yogaratnakara with Vidyaprabha Hindi Commentary. Netrarogadhyaya, verse 198-199. 4th ed. Choukhamba Krishnadas Academy. 2013, p.778., Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 60(mg), Frequency: bd, Duration: 45 Days
2Intervention ArmDrugClassical(1) Medicine Name: Dashanga haritaki, Reference: Tewari P. Vrindamadhava or Siddha Yoga. Netrarogadhikar, verse 230-234, 1st ed. Chaukhamba Vishwabharti. 2007. P.599., Route: Oral, Dosage Form: Modaka , Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
3Comparator ArmProcedure-a~jjanam, अंजनम् (Procedure Reference: Kaviraj Govind das. Bhaishajya Ratnavali, Siddhiprada commentary. In: Bhav Mishra, ed. Netrarogadhikara, verse 98-99. Chaukhambha Surbharati Publication. 2014. p 992., Procedure details: Local application (Anjana) from Kaneenaka to Apanga sandhi 60mg twice daily Morning (6-7 AM) & evening time (6-7 PM) )
(1) Medicine Name: Shankhadyanajana, Reference: Kaviraj Govind das. Bhaishajya Ratnavali, Siddhiprada commentary. In: Bhav Mishra, ed. Netrarogadhikara, verse 98-99. Chaukhambha Surbharati Publication. 2014. p 992., Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 60(mg), Frequency: bd, Duration: 45 Days
4Comparator ArmDrugClassical(1) Medicine Name: Shatavaryadi Churna, Reference: Shastri B. Yogratnakara with Vidyotini Hindi commentary. Netrarogadhikara, verse 272, 372. Chaukhambha Publication. 2015., Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: - Ghrita and Madhu in unequal amount), Additional Information: -
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Patients presenting with signs and symptoms of Timira (Simple Myopia), described as per Ayurvedic and modern science irrespective of gender, occupation and religion.
2. Having spherical equivalent refraction between -0.50 diopter and -6.00 diopter. (calculated by adding the sum of the sphere power with half of the cylinder power.)
3. Willing to comply with applying Anjana twice daily and follow the clinical trial visit schedule as per the study protocol.
 
 
ExclusionCriteria 
Details  1. Patients having high myopia (>6 Diopter) or pathological myopia (>8 Diopter) with degenerative retinal changes.
2. Patients having any other ocular pathology, e.g., strabismus, amblyopia, cataract, corneal opacity, iridocyclitis, retinal disease etc. will be excluded.
3. History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity, DM type 1).
4. Patients with the history of refractive correction through orthokeratology & refractive surgeries, etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in visual acuity using LogMAR chart.  baseline, 46th day 
 
Secondary Outcome  
Outcome  TimePoints 
• Change in Spherical equivalent refraction
• Comparative efficacy of both the groups on asthenopic symptoms.
• Pharmacognostic & physico-chemical study of Katakaphaladi Varti Anjana
• Assessment of Ocular toxicity of Katakaphaladi Varti Anjana.
 		 baseline, 46th day 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/11/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The rising prevalence of myopia is a major challenge worldwide, giving rise to an epidemic in certain regions. It is the most common refractive error and an important cause of ocular morbidity especially affecting school-going children and young adults. One of the prime fields of interest in Urdhwajatrugata Roga is Netra Vigyana & as a result, a detailed history, anatomical, physiological, pathological aspects & management related to eyes are described in the Samhitas. The disorders related to partial or complete loss of vision are defined under Drishtigata Roga. Among these, initial mild visual disturbances occur in Timira which when not treated properly at appropriate time can result into complete loss of vision seen in Linganasha. Timira, on the basis of symptoms can be correlated with refractive error, mainly myopia. Myopia or short-sightedness usually affects children & adolescents progressing up to age 16 or more. Simple myopia refers to the refractive error of -6 dioptre or less.

In Ayurveda, many modalities are mentioned which may provide relief in this condition, hold the progression and in some cases preventing it altogether. Therefore, an attempt will be made through this study. A study to evaluate comparative effect of Shatavaryadi Churna orally and Shankhadyanajana on Timira (Simple myopia) has been carried out previously by Dr. D. Naveen at Dr. N.T.R. University of Health Sciences, Vijaywada, Andhra Pradesh. This study gave 60% relief in the primary symptom i.e., Avyaktadarshana & 53.33% patients gained visual efficacy of 100% after the treatment in group getting intervened with both oral drug and Anjana. The present study aims to establish greater effect than the previous study. Kaptakaphaladi Anjana & Dashanga Haritaki Modaka orally has been selected for this study to evaluate their efficacy compared to the drugs used in previous study i.e., Shankhadyanjana & Shatavaryadi Churna orally in reducing the symptoms of Timira (simple myopia) and also check the progression of Timira (simple myopia).

RESEARCH QUESTION

What is the efficacy of local application of Katakaphaladi Varti Anjana (approx. 60mg two times a day for 45 days) along with oral administration of Dashanga Haritaki Modaka (6 g two times a day for 45 days) as compared to Shankhadyanjana (60 mg two times a day for 45 days) along with Shatavaryadi Churna (6 g two times a day with Madhu & Ghrita for 45 days) orally in the management of Timira- simple myopia?

NULL HYPOTHESIS (H0)

Local application of Katakaphaladi Varti Anjana along with oral administration of Dashanga Haritaki Modaka does not give better results than the local application of Shankhadyanjana along with oral administration of Shatavaryadi Churna in the management of Timira- simple myopia.

ALTERNATE HYPOTHESIS (H1)

Local application of Katakaphaladi Varti Anjana along with oral administration of Dashanga Haritaki Modaka is more effective than local application of Shankhadyanjana along with oral administration of Shatavaryadi Churna in the management of Timira- simple myopia.


 
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