| CTRI Number |
CTRI/2020/04/024501 [Registered on: 07/04/2020] Trial Registered Prospectively |
| Last Modified On: |
27/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of kshaudra yukta daruharidra kashay parishek with kantakari mul sidhha dugdh parishek in simple allergic conjunctivitis |
|
Scientific Title of Study
|
A Randomized controlled clinical trial to evaluate efficacy of kshaudra yukta Daruharidra kashay parishek with kantakari mul siddha dugdha parishek in 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 |
DrGaikwad Mohini Mahadu |
| Designation |
PG student |
| Affiliation |
PDEAS college of ayurved and research centre akurdi Pune |
| Address |
PDEAS Ayurved rugnalaya and sterling multi speciality hospital, vithhal rukhmini road no27, shalakyatantra opd no 122, nigdi pradhikaran, pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7744070102 |
| Fax |
|
| Email |
mohinizende2910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drchandana virkar |
| Designation |
HOD shalakyatantra |
| Affiliation |
PDEAS college of ayurved and research centre, Akurdi, pune |
| Address |
PDEAS college of ayurved and research centre,sector no 25 nigdi pradhikaran,Pune.PDEAS ayurved rugnalaya and sterling multi speciality hospital, sector no 27,nigdi pradhikaran,pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9822199107 |
| Fax |
|
| Email |
virkar.chandana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGaikwad Mohini Mahadu |
| Designation |
PG student |
| Affiliation |
PDEAS College of ayurved and research centre akurdi pune |
| Address |
PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE, third floor, shalakyatantra department, sector no 25, nigdi pradhikaran, PUNE.
Pune
MAHARASHTRA
411044
India |
| Phone |
7744070102 |
| Fax |
|
| Email |
mohinizende2910@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS college of ayurved and research centre,third floor, shalakyatantra department sector no25,nigdi pradhikaran Pune |
|
|
Primary Sponsor
|
| Name |
Principal PDEAS college of ayurved and research centre |
| Address |
PDEAS college of ayurved and research centre, sector no 25, nigdi pradhikaran, pune, 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 |
| DrGaikwad Mohini Mahadu |
PDEAS ayurved rugnalaya and sterling multi speciality hospital nigdi pradhikaran Pune |
Vithhal rukhmini road sector no 27 shalakyatantra opd no 122 nigdi pradhikaran Pune 411044
Pune
MAHARASHTRA |
7744070102
mohinizende2910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Comparator Agent |
Kantakari mul sidhha dugdh parishek |
Group B will be treated with kantakari mul sidhha dugdh parishek. Parishek will be poured on closed eyes of patient from height of 4 angula for 400 vakmatra Kala approximately 4-5 min. Quantity of parishek is 500ml.once a day for 5 days in age group of 18 to 60 which includes follow up on 7th, 15th day. |
| Intervention |
Kshaudra yukta daruharidra kashay parishek with kantakari mul sidhha dugdh parishek |
Group A Will be treated with kshaudra yukta daruharidra kashay parishek. Parishek will be poured on closed eyes of patient from the height of 4 angula for 400 vakmatra Kala approximately 4-5 min. Quantity of parishek is 500ml.once a day for 5 days in age group of 18 to 60 which includes follow up on 7th,15th day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patient having itching, burning sensation, watery discharge.
2.Edema of eyelids, pricking sensation. |
|
| ExclusionCriteria |
| Details |
1.known case of congenital anomalies of eye.
2.one eyed patient. 3.conjunctivitis with corneal involvement. 4.known case of bacterial conjunctivitis, viral conjunctivitis and with any other ocular infection. |
|
|
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 compare and study the efficacy of kshaudra yukta daruharidra kashay parishek once in a day for 5 consecutive days as compared to kantakari mul sidhha dugdh parishek once in a day for 5 consecutive days in simple allergic conjunctivitis. |
15 days with follow up on 7th and 15 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effect of the drug if any. |
15 days with follow up on 7th, 15th day. |
|
|
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)
|
07/04/2020 |
| 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 yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Allergic conjunctivitis is the most common type of eye allergy and is widely experienced by the global population. Eye being the most exposed organ to the environment, the disease like allergic conjunctivitis is very common now a days. The prevalence is 5 to 22% in general population. In modern medicine corticosteroids and anti histamine are mostly used for treatment of simple allergic conjunctivitis but longer use of these medicines increases chances of cataract, glaucoma. Allergic conjunctivitis can be cure by ayurvedi procedure like parishek with the help of medicinal formulation of daruharidra. |