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CTRI Number  CTRI/2022/06/043191 [Registered on: 13/06/2022] Trial Registered Prospectively
Last Modified On: 25/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of HARITIKYADI VARTI ANJANA and BHASKARADI GHRITA orally in the management of TIMIRA- simple Myopia  
Scientific Title of Study   EFFICACY OF BHASKARADI GHRITA WITH AND WITHOUT HARITKYADI VARTI ANJANA IN THE MANAGEMENT OF TIMIRA - SIMPLE MYOPIA- A RANDOMIZED DOUBLE ARM COMPARATIVE CLINICAL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himani Sharma 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda 
Address  5th floor, Academic Block, All India Institute of Ayurveda, Mathura Road, Gautam Puri, New Delhi 110076

South
DELHI
110076
India 
Phone  9354815051  
Fax    
Email  himani17796@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ankur Tripathi  
Designation  Assistant professor  
Affiliation  All India Institute of Ayurveda  
Address  5th floor Academic block, All India Institute of Ayurveda, Gautam Puri, Mathura Road, Sarita Vihar New Delhi 110076

South
DELHI
110076
India 
Phone  7888438512  
Fax    
Email  drankuraiia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ankur Tripathi  
Designation  Assistant professor  
Affiliation  All India Institute of Ayurveda  
Address  5th floor Academic block, All India Institute of Ayurveda, Gautam Puri, Mathura Road, Sarita Vihar New Delhi 110076

South
DELHI
110076
India 
Phone  7888438512  
Fax    
Email  drankuraiia@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda, Mathura Road, Gautam Puri, 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 
Himani Sharma  All India Institute of Ayurveda  Mathura Road, Gautam puri, New Delhi
South
DELHI 
9354815051

himani17796@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee All India Institute of Ayurveda  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 ArmDrugClassical(1) Medicine Name: Haritikyadi Varti Anjana, Reference: Chikitsa Sara Sangraha, Route: Ocular, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 60(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Nil
2Comparator ArmDrugClassical(1) Medicine Name: Bhaskaradi Ghrita, Reference: Chikitsa Sara Sanraha, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: -Nil
3Intervention ArmDrugClassical(1) Medicine Name: Bhaskaradi Ghrita, Reference: Chikitsa Sara Sangraha, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: Nil
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Patients between the age group of 10-30 years.
2 Patient presenting Sign and Symptoms of
Timira.3.Patient having myopia supto 6.0 D 
 
ExclusionCriteria 
Details  1) Patients not willing to participate in the study.
2) Patients having other uncontrolled systemic disease or metabolic disorders such as hypertension, diabetic
mellitus and thyroid and any other illness
3) Patients having any lenticular or Corneal opacity and any other known ocular pathology such as optic
atrophy, diabetic retinopathy and hypertensive retinopathy.
4) Pathological myopia
5) History of any surgical intervention to eye.during and immediately after surgery. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the clinical features of Timira i.e. blurred vision and change in refractive power.  0 day, 15th day, 30th day, 45th day, 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
Change in the other clinical features of Timira i.e. headache, watering, eye strain, diplopia, burning sensation,
and floaters. 
0 day, 15th day, 30th day, 45th day, 60th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   13/06/2022 
Date of Study Completion (India) 24/02/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 25/02/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  In the form of research articles.

  6. For how long will this data be available start date provided 13-04-2023 and end date provided 13-04-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  
INTRODUCTION
Eye disease are much more important than any other physical disability, because once the vision is lost then that
person is disabled for doing all regular activities and day & night are same for the person. Alochaka pitta is
considered responsible factor of visual perception i.e. of all the Mahabhootas, Tejas dominates, so the eyes are
especially susceptible and prone to kapha. That’s why the factors, which are vitiating Pitta or Kapha will lead
to eye disorders.
Timira is one among the Drishtigata Roga explained by all the Acharyas, that starts with simple visual
disturbance (Avyakta Darshana) but if unattended may lead to complete loss of vision (Linganasha). Therefore,
it is a “Paramdarun vyadhi”. Due to this reason all the Acharyas have paid special attention to this disease. The
clinical features of Timira (first Patalashrita- Avyakta Darshana- indistinct distance vision and second
Patalashrita- Vihwala Darshana, -blurred vision) can be correlated symptomatically with refractive errors.4
The symptom of Timira is “Avykta nisaroopani sarvane vyaprapashyati” i.e. blurring of vision, which is
cardinal symptom of refractive errors and the clinical features closely resembles Myopia 
Myopia or short-sightedness is a type of refractive error in which parallel rays of light coming from infinity are
focused in front of the retina when accommodation is at rest. Myopia is a highly significant problem not only
because of its high prevalence, but also because it can contribute to visual morbidity and increase the risk for
vision threatening conditions e.g. Retinal breaks and Detachment, Glaucoma etc. 
The basic treatment of Timira includes Snehan, Raktamokshana, Virechana, Nasya, Anjana, Shirobasti, Basti,
Tarpan, Lepa, and Seka that are to be followed repetedly. Among theses snehana and Anjana will be
followed in this study. On the basis of symptoms, Myopia can be correlated with Vata predominant Timira.
Hence line of management of Vataj Timira has been adopted.
The Chakshushya, Rasayana and Tridosha mitigating action might be helpful in such type of disorders.
Majority of Rasayana drugs work on multiple areas and helps in achievement of Vata shamana through its
Dipana, Pachana and Medhya properties. Thus, a drug having both Chakshushya and Rasayana properties can
be helpful regeneration of eye sight. Ghrita is one among the best Rasayana drug and Chakshushya property
might be helpful for treating the disease Timira ( Simple Myopia). According to Charaka, Ghrita improves
Dhatus and is overall booster for Ojas. It has the quality of trespassing into minute channels of the body, it
enters deeper layer of dhatus and cleanses every minute part of them.Bhaskaradi ghrita having ingredient
pippali, sharkara, draksha and madhuyashthi, mentioned in Chikitsa Saar Sangrah is one such Ayurveda
formulation having Balya, Chakshushya and Rasayan properties. Therefore, we have planned to study the effect
of Bhaskaradi Ghrita in the management of Timira( Simple Myopia).
Among the several types of treatment modalities local treatment are very specific, effective and unique to the
eye disease and called as Netra Kriyakalpa viz. Akshi Tarpan, Putapaka, Seka, Aschyotan, Anjana, Bidalaka,
and Pindi. The first five procedures are mentioned in Sushrut Samhita and last two are added by
Sharangdhar Samhita along with five procedure. In all Kriyakalpas, Anjana has unique therapeutic efficacy
for various types of ophthalmic disease and highly recommended as preventive measures of various eye
disorders. Anjana is procedure of applying medicine in the form of Gutika, Raskriya or Churna (powder) to the
innesr side of lower lid either by fingertip or by Anjana shalaka. Various ancient Acharyas described Anjana
therapy as a daily regimen especially Sauvira Anjana (Antimony sulphide) and Rasanjana (decoction of
Berberista aristata- Daruharidra) mixed with honey as it eliminates excessive Kapha Dosha from the eye
because eyes have predominance of Pitta Dosha or Teja Mahabhuta for its proper functioning or clarity of
vision. Therefore a clinical study is planned to study the efficacy of Bhaskaradi Ghrit orally with and without
Haritikyadi Varti Anjana in reducation in diopteric power and visual improvement.
 
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