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CTRI Number  CTRI/2023/08/056608 [Registered on: 17/08/2023] Trial Registered Prospectively
Last Modified On: 13/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To see the effect of Chakshushya Basti followed by Triphaladi Ghrita Aschyotana and Triphalayasadi Yoga orally in Timira (Simple Myopia). 
Scientific Title of Study   Clinical evaluation of Chakshushya Basti followed by Triphaladi Ghrita Aschyotana and Triphalayasadi Yoga orally in Timira (Simple Myopia) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jasmeen Saini 
Designation  PG Scholar 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan  
Address  OPD 1, Department of Shalakya-Tantra, Patanjali ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405

Hardwar
UTTARANCHAL
249405
India 
Phone  9872755662  
Fax    
Email  jspabla20@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Anil Verma 
Designation  HOD and Professor 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  OPD 1, Department of Shalakya-Tantra, Patanjali ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405

Hardwar
UTTARANCHAL
249405
India 
Phone  9897298775  
Fax    
Email  dranilverma11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jasmeen Saini 
Designation  PG Scholar 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  OPD 1, Department of Shalakya-Tantra, Patanjali ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405

Hardwar
UTTARANCHAL
249405
India 
Phone  9872755662  
Fax    
Email  jspabla20@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar 
 
Primary Sponsor  
Name  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar, uttarakhand -249405 
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 
Jasmeen Saini  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan  OPD 1, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road Haridwar, uttarakhand, 249405
Hardwar
UTTARANCHAL 		 9872755662

jspabla20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar  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: triphalayasadi yoga, Reference: Gadanigraha (Shalakyadi – Panchkarmadhikaranto Bhaga), Rasayan Tantra, Aushadhikalpadhikara, Triphala Kalpa. 2/120-123, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -ghrita, madhu), Additional Information: -
2Intervention ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: sushruta samhita, uttartantra , 18/45, Procedure details: aschyotana for 45 days)
(1) Medicine Name: triphaladi ghrita, Reference: Ashtanga-hridyam, Uttarsthana, 13/10-11, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: od, Duration: 45 Days
3Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Ashtanga-hridyam, Kalpasidhisthana, 4/27-28, Procedure details: siddha basti for 8 days)
4Comparator Arm (Non Ayurveda)-placeboplacebo topically and orally
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Patients with classical symptoms of Timira and simple myopia (up to -6D).
2. Patients between the age group of 8 years to 30 years of either sex.
3. Patients with symptoms like blurring of vision and short-sightedness.
 
 
ExclusionCriteria 
Details  1. Patients having age less than 8 years and more than 30 years.
2. Patients having high myopia (>6D).
3. Patients suffering from any other eye diseases like corneal xerosis, corneal ulcer, corneal opacity, cataract, diabetic retinopathy, macular degeneration etc. retinal diseases.
4. Patients suffering from other systemic diseases & metabolic disorders.
5. Patients with classical contra-indicatory conditions for Basti. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
assessment will be made on the basis of subjective & objective criteria.
blood investigation - CBC to exclude any systemic disease, HbA1C to exclude diabetes. 		 0, 3 weeks, 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
assessment will be made on the basis of subjective & objective criteria.
blood investigation - CBC to exclude any systemic disease, HbA1C to exclude diabetes. 		 0, 3 weeks, 8 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   24/08/2023 
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="5"
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  
This study is a Clinical Evaluation of Chakshushya Basti followed by Triphaladi Ghrita Aschyotana and Triphalayasadi Yoga orally in timira (Simple myopia)”. This will be conducted on 60 patients from OPD/IPD of Shalakya - Tantra Department of Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar. Patients will be divided into two groups - 30 patients will be given Chakshushya Basti followed by Triphaladi Ghrita Aschyotana and Triphalayasadi Yoga orally and 30 patients will be given Placebo topically and orally. 1st follow up after 15 days of basti treatment and 2nd follow up at the completion of treatment. Assessment will be done on the basis of subjective and objective parameters as discussed earlier.

 
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