| CTRI Number |
CTRI/2019/02/017484 [Registered on: 05/02/2019] Trial Registered Prospectively |
| Last Modified On: |
24/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of Madhu Shigru Aschyotana and Jatimukuladi Varti in the management of simple allergic conjunctivitis |
|
Scientific Title of Study
|
A Comparitive Study On The Efficacy Of Jatimukuladi Varti and Madhu Shigru Aschyotana In The Management Of Kaphaj Abhishyanda With Special Reference To Simple Allergic Conjunctivitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Verma |
| Designation |
Post Graduate Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Opd No 102,Department of Shalakya Tantra, All India Institute Of Ayurveda,Gautampuri, Sarita Vihar, New Delhi
Opd No 102,Department of Shalakya Tantra, All India Institute of Ayurveda, Gautampuri,Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
8810251767 |
| Fax |
|
| Email |
nidz.bhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pankaj Kundal |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no. 510, Academic Block ,All India Institute of Ayurveda, Gautampuri, Sarita Vihar,New Delhi
Room no. 510, Academic Block, All India Istitute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
729187810 |
| Fax |
|
| Email |
drpankajkundal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Pankaj Kundal |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no. 510 ,Academic Block, All India Institute of Ayurveda,Gautampuri, Sarita Vihar , New Delhi
Room no. 510 ,Academic Block, All India Institute of Ayurveda,Gautampuri, Sarita Vihar , New Delhi
West
DELHI
110076
India |
| Phone |
729187810 |
| Fax |
|
| Email |
drpankajkundal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda,Gautampuri, Sarita vihar, New Delhi |
|
|
Primary Sponsor
|
| Name |
All Iindia Institute of Ayurveda |
| Address |
All India Institute of Ayurveda Gautampuri, Sarita Vihar, New Delhi |
| 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 |
| dr nidhi verma |
All India Institute of Ayurveda |
Department Of Shalakya Tantra,EYE OPD,Room No. 102,Hospital Block
South
DELHI |
8810251767
nidz.bhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
people suffering from simple allergic conjunctivitis |
| Patients |
(1) ICD-10 Condition: H108||Other conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jatimukuladi Varti |
OD, Local Application, 3 weeks |
| Comparator Agent |
Madhu, Shigru |
2 Drops both eyes, BD, Topical Instillation, 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
itching mucus ropy discharge repeated lacrimation heviness of lids photophobia foreign body sensation burning sensation mid papillary response hyperemia chemosis |
|
| ExclusionCriteria |
| Details |
patients not willing for trial and follow up
viral and bacterial conjunctivitis vernal keratoconjunctivitis atopic keratoconjunctivitis giant papillary conjunctivitis phlyctenular conjunctivitis trachoma chalazion stye pterygium dacryocystitis trichiasis corneal opacity corneal ulcerrs hypertension diabetes mellitus tuberculosis
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the efficacy of jatimukuladi varti and madhu shigru aschyotana in the management of kaphaj abhishyanda |
3 weeks of Administration of Drugs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Restore or Maintain Normal Visual Function
To Prevent or Reduce the Likelihood of Damage to the Ocular Surface in respect to Allergic Conjunctivitis |
3 weeks after Administartion of Drugs |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
03/05/2019 |
| 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="5"
Days="23" |
|
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
|
A clinical trial for comparing the efficacy of madhu shigru aschyotana and jatimukuladi varti in the management of kaphaj abhishyanda with special referance to simple allergic conjunctivitis.
|