| CTRI Number |
CTRI/2018/08/015540 [Registered on: 30/08/2018] Trial Registered Prospectively |
| Last Modified On: |
28/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effect of mahaneela varti anjana in avarna shukla ayurvedic drug trial on avarna shukla. |
|
Scientific Title of Study
|
A Single-arm clinical study of mahaneela varti anjana in avarna shukla |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Shubhangi Bhausaheb Mhaske |
| Designation |
MS Scholar Shalakyatantra(Ayurved) |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyala |
| Address |
OPD NO.9, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune-411028
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411028
India |
| Phone |
9404774570 |
| Fax |
|
| Email |
shubhangimhaske27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMrs Nilakshi S Pradhan |
| Designation |
Head of the Department ,Professor |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyala |
| Address |
OPD NO.9, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune-411028
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Shubhangi Bhausaheb Mhaske |
| Designation |
MS Scholar |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD NO.9, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune-411028
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411028
India |
| Phone |
9404774570 |
| Fax |
|
| Email |
shubhangimhaske27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra,Sane Guruji Arogya kendra malwadi raod Hadaspsar Pune |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra
Malawadi Road Hadapsar Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vd Shubhangi bhausaheb Mhaske |
Vd Shubhangi Bhausaheb Mhaske |
OPD NO.9, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune-411028
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9404774570
shubhangimhaske27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Avarna shukla,corneal opacity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mahaneela varti Anjana |
Combination of fine powdered drugs including brihati,yashtimadhu,shunti,aamlaki,tamra,shaindhav triturating in Aamalaki rasa dose-application anjana apllied by shalakas
frequency-twice a day
administartion-tropical
duration-21 days
|
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients suffering form signs and symptoms Avarna shukra(corneal opacity grade 1 and 2) |
|
| ExclusionCriteria |
| Details |
Svrana shukla,anjana anarha,corneal opacties with complications like adherent leucoma,corneal facet,kerectasia anterior staphyloma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of mahaneela varti anjana in Avrana shukla |
The drug will be given for 21 days.the patients will be assessed before and after treatment.total duration of study will be 18 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To get relief from symptoms of Avarna shukla |
18 months |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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 |
|
Date of First Enrollment (India)
|
10/09/2018 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is open labelled single arm clinincal trial to see the effect of mahaneela varti anjana for 21 days in affected eye with avarna shukla.primary outcome will be effect of anjana on avarna shukla. |