| CTRI Number |
CTRI/2018/07/015126 [Registered on: 31/07/2018] Trial Registered Prospectively |
| Last Modified On: |
28/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
a study to find the combined effect of anutaila nasal instillation,mahoushada collyrrium ,jeevanthyaadi ghrita retension therapy around the eyes in dry eye syndrome |
|
Scientific Title of Study
|
Pre and post study to assess the combined effect of Anutaila nasya,mahoushada anjana and jeevanthyaadi ghrita tarpana in dry eye syndrome(shushkashipaka) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepthi K Nair |
| Designation |
PG Scholar |
| Affiliation |
Amrita school of Ayurveda |
| Address |
Amrita School Of Ayurveda
clappana PO vallikavu kollam
clappana PO vallikavu kollam
Kollam
KERALA
690525
India |
| Phone |
7558988636 |
| Fax |
|
| Email |
deepthinaveen2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Sivabalaji |
| Designation |
Assistant Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda
clappana PO vallikavu kollam
Amrita School of Ayurveda
clappana PO vallikavu kollam
Kollam
KERALA
690525
India |
| Phone |
7559027947 |
| Fax |
|
| Email |
balajisiva85k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Sivabalaji |
| Designation |
Assistant Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda
clappana PO vallikavu kollam
Amrita School of Ayurveda
clappana PO vallikavu kollam
Kollam
KERALA
690525
India |
| Phone |
7559027947 |
| Fax |
|
| Email |
balajisiva85k@gmail.com |
|
|
Source of Monetary or Material Support
|
| amrita life
pharmaceuticals
clappana PO vallikavu kollam
|
|
|
Primary Sponsor
|
| Name |
deepthi k nair |
| Address |
Amrita School of Ayurveda
clappana PO vallikavu kollam
|
| Type of Sponsor |
Other [NA] |
|
|
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 |
| deepthi k nair |
amrita School of ayurveda |
Amrita School of Ayurveda
clappana PO vallikavu kollam
Kollam
KERALA |
7558988636
deepthinaveen2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| amrita institute of medical sciences kochi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients with dry eye syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
anu taila nasya
mahoushada anjana
jeevanthyaadi ghritra tarpana |
anutaila dose 8 bindu in each nostrills for 5 days
mahoushada anjana 1 vela mathra for 5 days
jeevanthyaadi ghrita 50gms for 5 days |
| Comparator Agent |
na |
na |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Satisfying the diagnostic criteria
Tear film Break up time less than 10sec
Schirmers test positive less than 10mm
Patients fit for Nasya Anjana Tarpana karmas
|
|
| ExclusionCriteria |
| Details |
Patient suffering from any systemic diseases like SLE Rheumatic arthritis Sjogrens Syndrome and receiving medication
Sever case of Dry Eye Syndrome with complications like corneal ulcer Uveitis Glaucoma
Patients having poorly controlled hypertension and diabetic mellitus
Patients who are using drug like antihistamines decongestants, hormonal therapy antidepressants dermatologic medication anti psychotic and chemotherapy medications
Women who are pregnant or lactating
Congenital anomalies of eye
Patient contraindicated for Nasya Anjana and Tarpana karma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in symptoms |
within one month |
|
|
Secondary Outcome
|
|
|
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)
|
15/08/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2018 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
published after copmletion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dry Eye Disease is recognized as a growing health problem and one of the
most frequent reasons for seeking eye care. In India, the rural as well as
urban population suffers from dry eye disease. The incidence is quite higher amongst
outdoor workers and people from rural areas with poor socioeconomic status and
also due to the modern life style and global warming, the population suffering
from dry eye disease are increasing day by day.
Hence there is a need to find
a safe and effective medication. The modern definition of dry eye disease is based on the concept of the
three layers of the tear film. Secondary factors such as pathological changes
to the eyelids, cornea, or conjunctiva, can themselves disturb the normal
function of the tear film.
Shushkakshipaka is one among the Sarvagatha
Netra Rogas characterized by; Gharsha
(Irritation), Kunita (Photophobia), Avila Darshana (Blurred vision), Toda (Pricking type of pain), Daha (Burning sensation) and Raktharaji (Congestion). So the symptoms of Dry eye syndrome can be co-related with the symptoms Shushkakshipaka mentioned in ayurvedic
classics
Anu
taila nasya, Mahoushada Anjana, Jeevanthyadi ghrita tarpana are mentioned
as a treatment of Shushkakshipaka both in Ashtanga gridaya and Susruta samhita
uttara sthana. The previous researches
have evaluated the efficacy of single combination. Here my present study aim is
to evaluate the combined effect of the Anu taila nasya, Mahoushada Anjana,
Jeevanthyadi ghrita tarpana in Dry eye syndrome (Shushkakshipaka).
This is a pre and post design where 40
patients of both sex, in an age limit of 10-70 yrs, fulfilling the diagnostic
criteria will be registered for the
present study according to inclusion criteria.
The patients will be selected from OPD & IPD of Department of Shalakyatantra,
Amrita school of Ayurveda Hospital, Vallikkavu, Kollam. Subjective and
Objective parameters before and after treatment will be recorded meticulously
and analysed by using appropriate statistical methods, the Paired t test and
Wilcoxon signed rank test with Bonferronni correction and final conclusion will be drawn. |