FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/01/039565 [Registered on: 19/01/2022] Trial Registered Prospectively
Last Modified On: 18/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Kriyakalpa In SHUSHKAKSHIPAKA 
Scientific Title of Study   Role Of Kriyakalpa In SHUSHKAKSHIPAKA (Evaporative Dry Eye) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyanka Rani 
Designation  Assistant Professor 
Affiliation  Rishikul Campus UAU Haridwar 
Address  Shushrut Bhawan PG department of Shalakya Tantra Rishikul Campus UAU Hardiwar Uttarakhand India

Hardwar
UTTARANCHAL
249401
India 
Phone  7500402154  
Fax    
Email  chauhanpriyanka40@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyanka Rani 
Designation  Assistant Professor 
Affiliation  Rishikul Campus UAU Haridwar 
Address  Shushrut Bhawan PG department of Shalakya Tantra Rishikul Campus UAU Hardiwar Uttarakhand India

Hardwar
UTTARANCHAL
249401
India 
Phone  7500402154  
Fax    
Email  chauhanpriyanka40@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanka Rani 
Designation  Assistant Professor 
Affiliation  Rishikul Campus UAU Haridwar 
Address  Shushrut Bhawan PG department of Shalakya Tantra Rishikul Campus UAU Hardiwar Uttarakhand India

Hardwar
UTTARANCHAL
249401
India 
Phone  7500402154  
Fax    
Email  chauhanpriyanka40@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus UAU Haridwar 
 
Primary Sponsor  
Name  Rishikul Campus UAU Haridwar 
Address  OPD no 05 PG Department of Shalakya Tantra Rishikul Campus UAU Haridwar 
Type of Sponsor  Government 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 
Preity Rawat  Rishikul Campus UAU Haridwar  OPD no 05 PG Department of Shalakya Tantra UAU Haridwar
Hardwar
UTTARANCHAL 		 9808705811

preityrawat10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee Rishikul Campus UAU Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H028||Other specified disorders of eyelid. Ayurveda Condition: SUSHKAKSHIPAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sekaH, सेकः (Procedure Reference: Yogratnakara, Procedure details: Poorva karma: Chitrakadi Vati 2 BD for Deepan-Paachan(3-7 days) will be given according to the koshta for patient. Pradhan Karma: instillation of decoction on the closed eyelids at the height of 4 Angula (8 cm height). Paschata Karma: clean the eyes with clean and sterelized soft cloth.)
(1) Medicine Name: Prapaundarikadi sekah, Reference: Yogratnakara, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 120(ml), Frequency: bd, Duration: 15 Days
2Intervention ArmProcedure-biDAlaka:, बिडालक: (Procedure Reference: Sharangadhara, Procedure details: Poorva karma: Chitrakadi Vati 2 BD for Deepan-Paachan(3-7 days) will be given according to the koshta for patient. Pradhan Karma: Application of drug paste over the skin of lids excluding the eyelashes. when the paste starts drying then remove the paste with lukewarm boiled water. Paschata Karma: Clean eyes with soft and sterelised muslin cloth.)
(1) Medicine Name: prapaundarikadi sekah, Reference: Yogratnakara, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 120(ml), Frequency: bd, Duration: 15 Days
(2) Medicine Name: Yashtiyadi lepa, Reference: Yogaratnakar, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 6(g), Frequency: bd, Duration: 15 Days
3Intervention ArmProcedure-Anjana (Procedure Reference: Shusruta Samhita, Procedure details: Poorva karma: Chitrakadi Vati 2 BD for Deepan-Paachan(3-7 days) will be given according to the koshta for patient. Pradhan Karma:Topical application of Anjana into lower fornix with a blunt thick probe two times a day. Paschata karma: Clean Anjana with lukewarm water or wipe Anjana with clean and sterelized soft cloth.)
(1) Medicine Name: Saindhavadi Anjana, Reference: Yogratnakara, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 90(mg), Frequency: bd, Duration: 15 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient presenting with clinical features of
Shushkakshipaka and Evaporative Dry Eye.
2.Visual activity- 6/6 to 6/12 and N.6 to N.8 both
eyes(best corrected).
3.Patient between age group of 20 to 60 years.
 
 
ExclusionCriteria 
Details  1.Patient having visual activity <6/12 to N.8
(best corrected).
2.Patient suffering from specific eye lid
disorders like Ectropion, Entropion, Anterior,
Blepharitis,Tumors,skin allergies(Acne
rosacea),Lagophthalmos.
3.Patient suffering from Aqueous deficiency dry
eye.
4.Patient having infective anterior segment
disorder.
5.Patient having systemic disease like DM,HTN,
RA.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in the clincial science and symptoms of Shushkakshipaka (Evaporative Dry Eye).  At 1st day,15th day,30th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in other signs and symptoms of Evaporative Dry Eye.  At 1st day,15th day,30th day. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/01/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Total 40 patients suffering from Shushkakshipaka (Evaporative Dry Eye) will be selected from the OPD & IPD of Shalakya Tantra department of Uttarakhand Ayurved University,Rishikul Campus Hospital HAridwar for this clinical study,irrespective of sex,religion,occupation etc.A detail proforma will be prepared on the basis of ayurvedic text and allied sciences.The patient fulfilling the inclusion and exclusion criteria will be registered on this proforma and scoring of different clinical features will be done on assessment criteria. 
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 - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [preityrawat10@gmail.com].

  6. For how long will this data be available start date provided 21-12-2021 and end date provided 21-12-2126?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Total 40 patients suffering from Shushkaksipaka (Evaporative Dry Eye) will be selected form O.P.D. & IPD of Shalakya Tantra department of Uttarakhand Ayurvedic University,Rishikul Campus Hospital HAridwar for thos clinical study,irrespective of sex,religion,occupation etc.A detail proforma will be prepared on the basis of ayurvedic text and allied sciences.The patient fulfilling the inclusion and exclusion criteria will be registered on this proforma and scoring of different clinical features will be done on assessment criteria. 
Close