| CTRI Number |
CTRI/2019/04/018830 [Registered on: 29/04/2019] Trial Registered Prospectively |
| Last Modified On: |
26/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of Guduchyadi Anjana and Olopatadine eye drops in the treatment of Allergic eye infection |
|
Scientific Title of Study
|
A standard controlled clinical study of Guduchyadi Anjana and Olopatadine(0.2%)eye drops in the management of 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 |
DrRujuta Prakash Chandanshive |
| Designation |
PG student |
| Affiliation |
PDEAs college of ayurveda and research centre |
| Address |
PDEAs college of ayurveda and research centre 3rd floor shalakya tantra department sector no25nigdi pradhiakran pune 411044
PDEAs college of ayurveda and research centre 3rd floor shalakya tantra department sector no25nigdi pradhiakran pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9673923087 |
| Fax |
|
| Email |
dr.rujuta22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrChandana Virkar |
| Designation |
HOD and Guide Shalakya Department |
| Affiliation |
PDEAs college of ayurveda and research centre |
| Address |
PDEAs college of ayurveda and research centre 3rd floor shalakyatantra department sector no25nigdi pradhiakran pune 411044
PDEAs college of ayurveda and research centre 3rd floor shalakyatantra department sector no25nigdi pradhiakran pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9822199107 |
| Fax |
|
| Email |
virkar.chandana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rujuta Prakash Chandanshive |
| Designation |
PG student |
| Affiliation |
PDEAs college of ayurveda and research centre |
| Address |
PDEAs college of ayurveda and research centre 3rd floor shalakyatantra department sector no25nigdi pradhiakran pune 411044
PDEAs college of ayurveda and research centre 3rd floor shalakyatantra department sector no25nigdi pradhiakran pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9673923087 |
| Fax |
|
| Email |
dr.rujuta22@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurveda and research centre 3rd floor shalakya department Akurdi pradhikaran sector 25 pune 44 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurveda and research centre |
| Address |
PDEAs college of ayurveda and research centre sector 25 akurdi pradhikaran 411044 |
| Type of Sponsor |
Private 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 |
| Dr Rujuta Prakash Chandanshive |
Ayurveda Rugnalaya and sterling multispeciality hospital |
Vithhal rakhumai road sector 27 nigdi pradhiakaran pune 411044 Name of opd shalakya tantra Number of opd 122
Pune
MAHARASHTRA |
9673923087
dr.rujuta22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H108||Other conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchyadi Anjana |
Guduchyadi anjana will be prepared by Vati kalpana mentioned in sharangdhar samhita(uttarkhand 13/98-99) and vati will be applied to
the patient by rolling two times on a coarse rock with the help of Madhu as anjana once a day for 7 days with follow up on every 7th day up to 28 days. |
| Comparator Agent |
Olopatadine Eye drop 0.2% |
Olopatadine Eye drops 0.2% will be given to the patient 2 drops once in day for 7 days with follow up on every 7th day upto 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
known case of simple allergic conjunctivitis
|
|
| ExclusionCriteria |
| Details |
1.known case of congenital anomalies of eye
2.known case of any other known occular pathology,conjunctivitis with corneal involvement
3.known case of bacterial conjunctivitis,viral conjunctivitis and any other occular infections
4.one eye patient |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Guduchyadi anjana and olopatadine0.2% eye drops in simple allergic conjunctivitis |
7 days with follow up on 7th,147th,21st and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effects if any |
28 days |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
06/05/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Simple allergic conjunctivitis is the most common form of occular allergy. It is caused due to seasonal allergens like grass, pollens, weeds, contact with animals, certain flowers and pollution. In modern medicine, allergic conjunctivitis is treated with steroids and H1 receptor antagonists which can be harmful. Allergic conjunctivitis can be curable by medicinal procedure like anjana with help of medicinal formulation of guguchi. |