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CTRI Number  CTRI/2024/06/068607 [Registered on: 10/06/2024] Trial Registered Prospectively
Last Modified On: 04/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate the action of Chandana Anjana and Tila Taila Padabhyanga in the management of Asthenopia. 
Scientific Title of Study   A randomized open-label controlled clinical study to evaluate the efficacy of Chandana Anjana and Tila Taila Padabhyanga in the management of Asthenopia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akshat Vashisth 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital 
Address  Room no 305 Department of PG Studies in Shalakya tantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru

Bangalore Rural
KARNATAKA
560082
India 
Phone  9035500421  
Fax    
Email  akshatvashisth1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naveen B S 
Designation  Professor and Head of Department 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Room no 305 Department of PG studies in Shalakya tantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru

Bangalore Rural
KARNATAKA
560082
India 
Phone  9844991405  
Fax    
Email  navs009@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Naveen B S 
Designation  Professor and Head of Department 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Room no 305 Department of PG studies in Shalakya tantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru

Bangalore Rural
KARNATAKA
560082
India 
Phone  9844991405  
Fax    
Email  navs009@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital, 21st k.m. Kanakapura Main Road, Udayapura Post, Bengaluru, Karnataka, 560082, India. 
 
Primary Sponsor  
Name  Dr Akshat Vashisth 
Address  Sri Sri College of Ayurvedic Science and research Hospital 21st KM, Kanakapura main road, Udayapura post, Bengaluru 560082 
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 Akshat Vashisth  SRI SRI COLLEGE OF AYURVEDA SCIENCE AND RESEARCH HOSPITAL  Room number 305 Department of PG Studies in Shalakya tantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru 560082 KARNATAKA
Bangalore Rural
KARNATAKA 		 9035500421

akshatvashisth1@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:H53-H54||Visual disturbances and blindness. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Pada Abhyanga, Procedure details: Abhyanga has to be done with Tila Taila for 5 min over the foot.)
(1) Medicine Name: Tila Taila, Reference: Charaka Samhitha, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Duration: 7 Days
2Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Charaka Samhitha, Procedure details: Abhyanga has to be done with Tila Taila for 5 min over the foot.)
(1) Medicine Name: Tila Taila, Reference: Charaka Samhitha, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Duration: 7 Days
3Comparator ArmProcedure-a~jjanam, अंजनम् (Procedure Reference: Sushruta Uttara Tantra Chapter 18, Procedure details: medicated paste or powder to be applied on the inner margin of the lower eyelid with the help of shalaka or fingertip)
(1) Medicine Name: Ela Anjana, Reference: Charaka Chikitsa Trimarmiya Adhyaya, Route: Ocular, Dosage Form: Churna/ Powder, Dose: 375(mg), Frequency: od, Duration: 7 Days
4Intervention ArmProcedure-a~jjanam, अंजनम् (Procedure Reference: Sushruta Uttara Tantra Chapter 18, Procedure details: medicated paste or powder to be applied on the inner margin of the lower eyelid with the help of shalaka or fingertip)
(1) Medicine Name: Chandana Anjana, Reference: Bhaisajya Ratnavali, Route: Ocular, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 375(mg), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Subjects within the age group between 21 to 40 years irrespective of gender, caste, religion, and socio-economic status.
2. Subjects having at least two symptoms under diagnostic criteria.
3. Subjects having vision as 6/6 or 6/6 blur or N6 or N6 blur up to ± 1D.
4. Subjects willing to participate in the study with informed consent. 
 
ExclusionCriteria 
Details  1. History of any intraocular surgery.
2. Subjects having any ocular trauma.
3. Subjects having any uncontrolled systemic illness that can interfere with the course of disease and treatment.
4. Subjects diagnosed with infective diseases of the eye like Conjunctivitis, Uveitis, Scleritis, Keratitis, Stye, Trachoma, Endophthalmitis, Blepharitis, Retinitis and Dacryocystitis.
5. Subjects having refractive errors due to pathological conditions like Cataracts, Corneal opacity, Keratoconus, and Glaucoma.
6. Pregnant and lactating women. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant improvement in the signs and symptoms of Asthenopia.
 		 Pre-treatment: 0th Day
Post Treatment: 8th Day
1st Follow-up: 15th Day
2nd Follow-up: 30th Day 
 
Secondary Outcome  
Outcome  TimePoints 
Generation of in-depth analyzed data on the different aspects of the disease.
Generation of data on possible adverse drug reaction.
 		 Pre treatment: 0th Day
Post Treatment: 8th Day
1st Follow up: 15th Day
2nd Follow up: 30th Day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   17/06/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Asthenopia is defined as a group of symptoms that includes difficulty in focusing, transient blurred vision, dull eye ache, and frontal headache. It also includes other symptoms like dry eye, eye strain, burning sensation, and increased lacrimation.
Asthenopia can occur when the ciliary muscles become tired from the continuous adjustment of the lens to focus on objects at varying distances. This may result from prolonged close-up tasks, extended periods of long-distance viewing, or in individuals with convergence insufficiency, phorias, extraocular muscle imbalances, uncorrected refractive errors, incorrect refractive corrections (particularly for astigmatism), or early presbyopia. 

RESEARCH QUESTION:

            Whether Chandana Anjana and Tila Taila Padabhyanga is effective in the management of Asthenopia?

HYPOTHESES:

Null Hypothesis (H0): There is no significant difference in the clinical efficacy of Chandana Anjana and Ela Anjana with Tila Taila Padabhyanga in the management of Asthenopia.

Alternative Hypothesis (H1): The efficacy of Chandana Anjana and Tila Taila Padabhyanga is better than Ela Anjana and Tila Taila Padabhyanga in the management of Asthenopia.

Alternative Hypothesis (H2): The efficacy of Ela Anjana and Tila Taila Padabhyanga is better than Chandana Anjana and Tila Taila Padabhyanga in the management of Asthenopia.

 
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