| CTRI Number |
CTRI/2019/03/018185 [Registered on: 20/03/2019] Trial Registered Prospectively |
| Last Modified On: |
12/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to see the effect of an Ayurvedic formulation in comparison with Olopatadine (0.1%) Eye Drop in allergic conjunctivitis |
|
Scientific Title of Study
|
An Open Labeled Randomized Controlled Clinical Trial to Evaluate Efficacy Of Kantakari Mula Siddha Kshira Ghrita Aschyotana And Olopatadine (0.1%) Eye Drop in Vataja Abhishyanda. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Nirupa Dattatray Ainlod |
| Designation |
M.S scholar Shalakyatantra (Ayurved Dhanvantari) |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College |
| Address |
OPD NO 9, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi Road, Hadapsar
Malwadi Road, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
8830844368 |
| Fax |
|
| Email |
nirupa.ainlod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravin M Bhat |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College |
| Address |
OPD NO 9, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi Road, Hadapsar
Malwadi Road, Hadapsar,
Pune
MAHARASHTRA
411028
India |
| Phone |
9860233173 |
| Fax |
|
| Email |
vdpravin82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravin M Bhat |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College |
| Address |
OPD NO 9, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi Road, Hadapsar
Malwadi Road, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
9860233173 |
| Fax |
|
| Email |
vdpravin82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
MAMs Sumatibhai Shah Ayurved College, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune-411028 |
| 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 Nirupa Dattatray Ainlod |
Sane Guruji Arigya Kendra |
Opd no 9, Departmenta
of Shalakyatantra, Sane
Guruji Arogya Kendra,
Malwadi, Hadapsar,
Pune-411028
Pune
MAHARASHTRA |
8830844368
nirupa.ainlod@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 |
(1) ICD-10 Condition: H10||Conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kantakarimula Siddha Kshira Ghrita Aschyotan |
Combination of Bharad of Kantakarimula, Ajadugdha, Goghrita. The drug will be prepared by snehasiddhi kalpana.
Dose-1drop
Frequency- Twice a day
Administration- Topical
Duration-10 days |
| Comparator Agent |
Olopatadine 0.1% eye drop |
Drug classification- Antihistamine
Administration-Topical
Dose-1 drop
Frequency- Twice a day
Duration- 10 DAYS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Vataja Abhishyanda shows Toda, Sangharsha, Shishirashruta, Alpa Shopha.
2)Age 18-60yrs, Gender- Male and Female.
3)Only those cases will be accepted for final assessment who successfully complete the treatment in given time.
|
|
| ExclusionCriteria |
| Details |
1)Pittaja, Kaphaja, Raktaja Abhishyanda.
2)Other ocular complications such as Corneal Opacity, Corneal Ulcer.
3)Patient suffering from other systemic disease such as Bronchial Asthma, Allergic Bronchitis, Dermatitis, Allergic Rhinitis, DM, HTN.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Kantakarimula siddha Kshira Ghrita Aschyotan as compared to Olopatadine 0.1% eye drop in Vataj Abhishyanda. |
Effect of Kantakarimula siddha Kshira Ghrita Aschyotan as compared to Olopatadine 0.1% eye drop in Vataj Abhishyanda. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Antihistaminic effect of Kantakarimula siddha Kshira Ghrita |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 LABELED RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF KANTAKARIMULA SIDDHA KSHIRA GHRITA ASCHYOTANA AS COMPARED TO OLOPATADINE 0.1% EYE DROP APPLIED TWICE DAILY FOR 10 DAYS IN EYES OF PATIENT AFFECTED WITH VATAJ ABHISHYANDA. THE PRIMARY OUTCOME WILL BE EFFECT OF ASCHYOTANA AND THE SECONDARY OUTCOME WILL BE ANTIHISTAMINIC EFFECT ON ALLERGIC CONJUNCTIVITIS |