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CTRI Number  CTRI/2020/06/026025 [Registered on: 22/06/2020] Trial Registered Prospectively
Last Modified On: 12/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study for Ayurvedic management of Simple Myopia. 
Scientific Title of Study   A randomized open label comparative clinical study to evaluate the efficacy of shigru pallava arka nasya and eye exercise in prathamapatalagata timira with special reference to simple myopia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep S 
Designation  PG scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Room no 306, Department of PG studies in Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura Road, Udayapura Road, Bangalore-82.

Bangalore
KARNATAKA
560082
India 
Phone  6282241564  
Fax    
Email  sandeepkottapuram@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandhya Ganesh K 
Designation  Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital 
Address  Room no 306, Department of PG studies in Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura Road, Udayapura Road, Bangalore-82.

Bangalore
KARNATAKA
560082
India 
Phone  9449349263  
Fax    
Email  drsandyaganeshk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandeep S 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital 
Address  Room no 306, Department of PG studies in Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura Road, Udayapura Road, Bangalore-82.

Bangalore
KARNATAKA
560082
India 
Phone  6282241564  
Fax    
Email  sandeepkottapuram@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital, 21st km, Kanakapura road, udayapura post, Bangalore-98 
 
Primary Sponsor  
Name  Dr Sandeep S 
Address  Room no 306, Department of PG studies in Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura Road, Udayapura post, Bangalore-82. 
Type of Sponsor  Other [Self] 
 
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 Sandeep S  Sri Sri College of Ayurvedic Science and Research Hospital  Room no 06,OPD - Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura Road, Udayapura post, Bangalore-82.
Bangalore
KARNATAKA 
6282241564

sandeepkottapuram@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Eye Exercise  8 exercises Time- morning Duration- 30 days Frequency - Once a day 1. Sunning 2. Eye wash 3. Palming 4. Candle Flame Concentration 5. Shifting and Swinging 6. Ball Exercise 7. Vaporization 8. Eye Pad  
Intervention  Nasya with Shigru Pallava Arka  Dose- 8 bindus in each nostril frequency - Once a day for 7 days Time- morning- empty stomach Duration-7 days Route of administration - Nasal  
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Subjects irrespective of their gender, caste and religion will be included
2. Subjects presenting with clinically established condition of Simple Myopia.
3. Optical correction ranging from -0.5D to -5Dsph
 
 
ExclusionCriteria 
Details  1. Pathological Myopia and High Myopia with degenerative changes, retinal changes and structural deformities like cataract and corneal opacity.
2. Subjects suffering from any of the systemic disorders (Hypertension,Diabetes, Tuberculosis, Syphilis), endocrinal or nutritional disorders.
3. Subjects who have underwent any of the refractive surgeries.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Snellens Visual Acuity and Auto-Refractive meter Reading  Baseline, 8th day, 31st day, 60th day of study period 
 
Secondary Outcome  
Outcome  TimePoints 
Subjective Improvement in asthenopic symptoms related myopia.  8th day, 31st day, 60th 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   Phase 3 
Date of First Enrollment (India)   01/08/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Simple Myopia is the most common clinical variety of Myopia (distant vision impairment) seen in children and in adults. Its symptoms include diminution of vision for distance in varying degrees depending on the amount of refractive error and Asthenopic symptoms such as eye strain, headache etc.

This symptom is mentioned as Avyaktha Darshana in Prathama Patalagata Timira, a stage of Timira described under Drushtigata Rogas.

The available treatments of refractive errors include using of power glasses and surgical treatment.

Soldiers, sailors, athletes, workmen and children have great difficulty with glasses because of the activity of their lives, which not only leads to breaking of the lenses but often throws them out of focus. At their best it cannot be maintained that glasses are anything more than a very unsatisfactory substitute for normal vision.

 Surgical intervention although popular is not affordable to everyone and may be associated with complications such as dry eye and night glare which can be annoying.

Thereby, due to these downsides, there is an immediate requirement of wholesome treatment measures which can manage this visual infirmity and ensure the disease does not progress. Acharyas of Ayurveda consider Indriyas (sense organs) as one of the vital components of Ayu(life), and have described various well designed treatment modalities comprising of Chakshushya dravyas, Netra kriyakalpas, relevant changes in Ahara and vihara, and other remedial strategies, which are said to escalate visual acuity, strengthen the indriyas and also avert consequent ocular complications.

Shigru  is a Chakshushya dravya indicated in many Netra vikaras. The Arka preparation of the same can be not only very potent but also a sterile form of medicine in the treatment of eye disorders. In this study an effort is made to evaluate the efficacy of Shigru Pallava Arka Nasya and Eye Exercise in the management of Prathama Patalagata Timira (Simple Myopia.) 
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