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CTRI Number  CTRI/2015/08/006068 [Registered on: 03/08/2015] Trial Registered Retrospectively
Last Modified On: 15/03/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dry eye syndrome and Ayurveda management 
Scientific Title of Study   A randomized controlled clinical trial on the management of Shushkakshi paka w. s. r. to Dry eye syndrome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kishor R Chudasama 
Designation  Research Scholar  
Affiliation  IPGT AND RA, G.A.U. JAMNAGAR 
Address  DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR GUJARAT DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9725470202  
Fax    
Email  krchudasama84@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Majusha Rajgopala  
Designation  Professor  
Affiliation  IPGT AND RA, G.A.U. JAMNAGAR 
Address  DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR GUJARAT DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9429094994  
Fax    
Email  bhatrajma2008@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kishor R Chudasama 
Designation  Research Scholar  
Affiliation  IPGT AND RA, G.A.U. JAMNAGAR 
Address  DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR GUJARAT DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR Jamnagar GUJARAT 361008 India


GUJARAT
361008
India 
Phone  9725470202  
Fax    
Email  krchudasama84@gmail.com  
 
Source of Monetary or Material Support  
IPGT AND RA GAU  
 
Primary Sponsor  
Name  IPGT AND RA GAU  
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujrat Ayurved University Jamnagar-361008  
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 
Kishor R Chudasama  IPGT AND RA  Room no 4 Netra roga opd ipgt and ra gau jamnagar Jamnagar GUJARAT
Jamnagar
GUJARAT 		 9725470202

krchudasama84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  sign and symptom of Shuskashipaka,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention Group  Triphaladi yoga (Anubhoota) Orally 500 mg Capsule, Thrice in a day 6 weeks Anu Tail Pratimarsha nasya 2 drops in each nostril 6 weeks Shunthyadi eye drops Eye drops 1 drop as per requirement 6 weeks  
Comparator Agent  Standard Control Group   Carboxymethyl cellulose 0.5 % eye drops Topical 1 drop as per requirement 6 weeks  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients presenting with signs and symptoms of Dry eye syndrome
Willing and able to participate in the study
 
 
ExclusionCriteria 
Details  1. Age group below 16 and more than 60 years.
2. Severe cases of dry eye syndrome with complications like perforated corneal ulcer, Uveitis, Glaucoma.
3. Allergic eye disease i.e. vernal keratoconjunctivitis, Giant papillary conjunctivitis.
4. Non specific topical beta blocker users.
5. Inflammatory conditions like acute conjunctivitis etc.
6. Patients on steroids, oral contraceptive pills, estrogen replacement therapy or any other medication that may adversely affect the outcome of the study
7. Patients with evidence of malignancy
8. Patients suffering from major systemic illness necessitating long term drug treatment i.e. Psycho-epileptic drug users.
9. H/o hypersensitivity to the trial drug or any of its ingredients.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
relief in sign and symptoms of Shuskashi paka  relief in sign and symptoms of Shuskashi paka 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/04/2015 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary    A clinical study is proposed to evaluate the efficacy of Triphaladi yoga (Anubhoot) orally, Anu tail for pratimarsha nasya and Shunthyadi eye drops topically in the management of Shushkakshipaka w.s.r. to dry eye syndrome. 
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