| CTRI Number |
CTRI/2019/07/020000 [Registered on: 02/07/2019] Trial Registered Prospectively |
| Last Modified On: |
21/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study On Role Of Jalaukavcharana And Yashtyadi Lepa In Hordeolum |
|
Scientific Title of Study
|
A Comparative Clinical Study On Role Of Jalaukavcharana And Yashtyadi Lepa In Anjananamika With Special Reference To Hordeolum |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prof Gunjan Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Rishikul Campus UAU Haridwar |
| Address |
room no. 5 P.G. Department of Shalakya Tantra
Rishikul Campus UAU Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8218428029 |
| Fax |
|
| Email |
gunjan06purity@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Gunjan Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Rishikul Campus UAU Haridwar |
| Address |
Room no. 5 P.G. Department of Shalakya Tantra
Rishikul Campus UAU Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8218428029 |
| Fax |
|
| Email |
gunjan06purity@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prof Gunjan Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Rishikul Campus UAU Haridwar |
| Address |
Room No.5 P.G. Department of Shalakya Tantra
Rishikul Campus UAU Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8218428029 |
| Fax |
|
| Email |
gunjan06purity@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus UAU Haridwar |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus |
| Address |
Rishikul Campus UAU Haridwar |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Ranjana Negi |
Rishikul Campus UAU Haridwar |
Room no.5 P.G. Department of Shalakya Tantra Rishikul Campus UAU Haridwar
Hardwar
UTTARANCHAL |
7060187856
rnranjanasmart181@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H000||Hordeolum (externum) (internum) ofeyelid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jalaukavcharana followed by Seka |
Jalaukavcharana foolowed by seka will be performed for 5 days on alternate days i.e. 3 sittings will be done on 1st,3rd and 5th day.in between only Seka with Yashtyadi Kwatha will be done i.e. on 2nd and 4th day |
| Comparator Agent |
Vidalaka karma with Yashtyadi Lepa followed by Seka |
Vidalaka with Yashtyadi Lepa will be done followed by Yashtyadi Kwatha Seka for 5 days |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients having signs and symptoms of Anjananamika and External and Internal Hordeolum |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of therapy, objectively all signs and symptoms were given scoring depending upon their severity:
1-Cured:91-100% relief in signs and symptoms
2-Markedly improvement:76-90% relief in signs and symptoms
3-Moderately improvement:51-75% relief in signs and symptoms
4-Mild improvement:26-50% relief in signs and symptoms
5-Unchanged/no improvement:less than or equal to 25% relief in signs and symptoms |
assessment will be done on 1st day ,3rd day and 5th day after trial. overall assessment after 5 days of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| exacerbation in signs and symptoms |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
14/07/2019 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
trial yet to be started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Ayurveda, the most rational and scientific among the ancient systems of medicine, has immense potential to tackle many medical problems. Sushruta Samhita has described 76 Netrarogas, out of which 21 are Vartmagata Vikaras.Anjananamika is one of the Vartmagata, Raktpradhan and Shastrakritya (bhedan) sadhya vyadhi.The clinical features of Anjanamika resemble with an eye disease named as Hordeolum. It is an acute infection (usually Staphylococcal) involving either the glands of Zeis (External Hordeolum) or the Meibomian glands(Internal Hordeolum).Anjananamika is a raktaj vyadhi and for its intervention jalaukavcharana, vidalak and seka is selected as all three help in curing raktaj or rakta-pitta vitiated disorders. In this study, effort is made in the form of use of localised treatment with Jaluakavcharana and Yashtyadi lepa followed by Seka and to find out a comparatively better alternate for Hordeolum among the both. The study will be intervened under 2 groups – group A ( Jalaukavcharana with Yashtyadi Seka and group B (Vidalaka with Yashtyadi lepa followed by Yashtyadi Seka) and duration of the trial will be of 5 days. The observation of patients will be carried out on day 1, on 3rd day and after completion of trial and after completion follow up will be done for 1 month
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