| CTRI Number |
CTRI/2013/06/003736 [Registered on: 11/06/2013] Trial Registered Retrospectively |
| Last Modified On: |
06/06/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Drakshadi Ghritapana, Vasanjana and Anutaila Nasya on Shushkakshipaka (Dry Eye Syndrome) |
|
Scientific Title of Study
|
A Clinical Study on Ayurvedic Treatment Protocol of Shushkakshipaka (Dry Eye Syndrome) with Drakshadi Ghritapana, Vasanjana and Anutaila Nasya. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jadhav Nandini Murli |
| Designation |
Ph.D. Scholar |
| Affiliation |
Institute for Post Graduate Teaching & Research in Ayurveda, Gujarat Ayurved University |
| Address |
Department of Shalakyatantra,
I.P.G.T. & R.A., Gujarat Ayurved University,
Jamnagar-361008
B/16, staff colony, Gujarat Ayurved University, Jamnagar-361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9277404342 |
| Fax |
|
| Email |
nandini.punarvasu17@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof K S Dhiman |
| Designation |
Professor & Head |
| Affiliation |
Institute for Post Graduate Teaching & Research in Ayurveda, Gujarat Ayurved University |
| Address |
Department of Shalakyatantra,
I.P.G.T. & R.A., Gujarat Ayurved University,
Jamnagar-361008
101/ Satkar apt., Near viral baug, jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
09723821965 |
| Fax |
|
| Email |
dr_ks_dhiman@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jadhav Nandini Murli |
| Designation |
Ph.D. Scholar |
| Affiliation |
Institute for Post Graduate Teaching & Research in Ayurveda, Gujarat Ayurved University |
| Address |
Department of Shalakyatantra,
I.P.G.T. & R.A., Gujarat Ayurved University,
Jamnagar-361008
B/16, staff colony, Gujarat Ayurved University, Jamnagar-361008
GUJARAT
361008
India |
| Phone |
9277404342 |
| Fax |
|
| Email |
nandini.punarvasu17@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute for post graduate teaching and research in Ayurveda, Gujarat Ayurved University, Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute for post graduate teaching and research in Ayurveda Gujarat Ayurved University Jamnagar |
| Address |
Institute for post graduate teaching and research in Ayurveda, Gujarat Ayurved University, Jamnagar. |
| 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 K S Dhiman |
Institute for post graduate teaching and research in Ayurveda, Gujarat Ayurved University, Jamnagar. |
OPD no. 4, Department of Shalakatantra, Institute for post graduate teaching and research in Ayurveda, Gujarat Ayurved University, Jamnagar.
Jamnagar
GUJARAT |
02882541413
02882676856
dr_ks_dhiman@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , IPGT & RA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Shushkakshipaka (Dry eye syndrome), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carboxymethyl cellulose eye drops (Ecotears) |
1 to 2 drops in the affected eye(s) twice daily |
| Intervention |
Drakshadi Ghrita & Vasanjana followed by Anutaila Nasya |
Drakshadi Ghrita- 25 gms at bed time with hot milk after completion of marsha nasya course.
Vasanjana-1 drop BD for 1 month
Anutaila Nasya- Marsha nasya -6 Bindus for 6 days once in a month in each nostril ,morning or evening. followed by pratimarsha nasya -2 Bindus in each nostril BD for 24 days after application of vasanjana |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with the symptoms suggestive of dry eye like irritation, foreign body(sandy) sensation, feeling of dryness, itching, non-specific ocular discomfort & classical symptoms of Shushkashipaka alongwith altered/effected QOL.
2.Patients age between 20-70 years and willing to participate in this study.
3.Tear film break up time less than 10 seconds.
4.Schirmers -1 test positive < 10 mm
5.Rose Bengal staining showing devitalized epithelium of conjunctiva and mucus plaques on the cornea.
Any two criteria out of 3/4/5 are positive,diagnosis of dry eye syndrome is confirmed. |
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate in this study.
2.Severe cases of dry eye syndrome with complications like perforated corneal ulcer, Uveitis, Glaucoma.
3.Inflammatory conditions like acute conjunctivitis etc.
4.Systemic diseases causing Dry Eye Syndrome. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in objective parameters like Schirmers -1 test, Rose Bengal staining, tear film breakup time, Fluorescein staining. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence during follow up period |
1 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2 |
|
Date of First Enrollment (India)
|
07/03/2013 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open clinical trial. This study aims at evaluating
the efficacy of Ayurvedic treatment protocol including Drakshadi Ghritapana,
Vasanjana and Anutaila Nasya in
management of Shushkakshipaka i.e. Dry eye syndrome. A standard control i.e.
Ecotear eye drops is being used as a comparator agent. A follow up study will be carried out for one month after completion of
treatment, subjecting to patients availability. The results will be assessed by
improvement in sign & symptoms of the disease and also based upon changes
in Objective parameters. |