| CTRI Number |
CTRI/2023/03/051076 [Registered on: 27/03/2023] Trial Registered Prospectively |
| Last Modified On: |
17/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Management of Shushkaakshipaka (Dry Eye Disease ) by using Shunthyadi Aschyotana (Eye Drop) with Mahatriphaladi Ghrita Pana and Mridweekaadi Aschyotana (Eye Drop) with Mahatriphaladi Ghrita Pana. |
|
Scientific Title of Study
|
Efficacy of Shunthyadi Aschyotana (Eye Drop) with Mahatriphaladi Ghrita Pana and Mridweekaadi Aschyotana (Eye Drop) with Mahatriphaladi Ghrita Pana in the management of Shushkaakshipaka (Dry Eye Disease) - An Open Labelled Randomized Comparative Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diptidipanita Sahoo |
| Designation |
MS Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
4th floor Department of Shalakyatantra Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
6371327523 |
| Fax |
|
| Email |
diptisahoo1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak K Pawar |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
4th floor Department of Shalakyatantra Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
7737379173 |
| Fax |
|
| Email |
drpawar29@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak K Pawar |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
4th floor Department of Shalakyatantra Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
7737379173 |
| Fax |
|
| Email |
drpawar29@itra.edu.in |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Institute of Teaching and Research in Ayurveda Opposite Reliance Mart Near B division police station Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Diptidipanita Sahoo |
Institute of Teaching and Research in Ayurveda |
Institute of Teaching and Research in Ayurveda Opposite Reliance Mart Near B division police station Jamnagar GUJARAT 361008
Jamnagar
GUJARAT |
6371327523
diptisahoo1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H049||Disorder of lacrimal system, unspecified. Ayurveda Condition: SARVAGATAKSHIROGAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shunthyadi Aschyotana, Reference: Anubhuta Yoga, Route: Ocular, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Mahatriphaladi Ghrita, Reference: Chakradatta Netraroga Cikitsa Prakarana , Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mridweekaadi Aschyotana, Reference: Sahastrayoga, Route: Ocular, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Mahatriphaladi Ghrita , Reference: Chakradatta Netraroga Chikitsa Prakarana , Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group 18-50 years irrespective of sex, caste, religion.
2. Patients having minimum three symptoms of Dry Eye Disease.
3. Patients having minimum 2 findings of below tests:
i. Schirmer strip wetting of between 1-15 mm in 5 minutes: Schirmer- I test.
ii. The appearance of dry spot between 1-15 seconds: Fluorescein Tear Film Break Up
Test (F-TBUT).
iii. Mild to Severe Staining (Superficial to dense staining): Fluorescein Staining.
iv. Mild to Severe Staining (Dot count 1-30): Rose Bengal Staining (Oxford scheme of scoring). |
|
| ExclusionCriteria |
| Details |
1.Age less than 18 years and more than 50 years.
2. Dry Eye due to any local cause e.g., Chemical Burn, Xerosis etc.
3. Dry Eye due to systemic disease like Sjogren’s Syndrome.
4. Patients on Steroids, Oral Contraceptive Pills, Estrogen Replacement Therapy or any
other medication such as Antispasmodic drugs like Atropine that may adversely affect
the outcome of the study.
5. Persistent contact lens users.
6. Patients having chronic debilitating diseases like HIV, Tuberculosis, Malignancy,
uncontrolled Diabetes Mellitus and Hypertensive.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in Subjective and Objective criteria of Shushkaakshipaka ( Dry Eye Disease). |
1-2 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Long-lasting effect of Ayurvedic intervention |
1-2 month |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Purpose of the Research: Shushkaakshipaka (Dry Eye Disease) is a disease which is elaborately
describe in Ayurveda under the heading of Sarvakshiroga. No remedical measures for the
prevention and cure of this pathology prevail in the domain of modern medicine except using
ocular surface lubricants, computer glasses and counselling for minimum computer use.Though
lubricating drops can reduce the effect of Dry Eye , but does not break the root of pathogenesis of
the disease.This limitation make us think about effective and alternative treatment of Dry Eye
Disease as Ayurvedic medicines mainly focus on treating the disease from its root cause.
Information on the Trial procedure and Drug: Here Group A will be given Shunthyadi
Aschyotana (Eye Drop), 1 drop 4 times per day (4 hourly) along with Mahatriphaladi Ghrita Pana
(15 ml) in empty stomach in the morning with Koshna Jala for 1 month. Group B will be given
Mridweekaadi Aschyotana (Eye Drop), 1 drop 4 times per day (4 hourly) along with
Mahatriphaladi Ghrita Pana (15ml) in empty stomach in the morning with Koshna Jala for 1
month.We assure that we will prepare all formulations with as per S.O.P in the Pharmacy of
I.T.R.A. Sterilized packaging of Eye Drops will be done at Indiana Opthalmics, Surendra Nagar,
under aseptic conditions.
Description of the Process: In present study, participants who will be clinically diagnosed and
confirmed cases of Shushkaakshipaka (Dry Eye Disease) enlisted in inclusion criteria will be
enrolled, minimum 30 patients and will be divided into 2 groups i.e Group A & Group B (minimum
15 patients in each group) by Computer Generated Random Sampling Method. In Group A ,they
will be given Shunthyadi Aschyotana (Eye Drop), 1drop 4 times per day (4 hourly) along with
Mahatriphaladi Ghrita Pana (15ml) in empty stomach in the morning with Koshna Jala for 1
month. In Group B, they will be given Mridweekaadi Aschyotana (Eye Drop), 1 drop 4 times per
day (4 hourly) along with Mahatriphaladi Ghrita Pana (15ml) in empty stomach in the morning
with Koshna Jala for 1 month. Follow-up: After completion of the treatment patient will be
followed up for 1 month at the interval of 15 days. Side Effects: We will follow closely and keep
track of any unwanted effects.We may use some other medicines or stop the usage of drug to
decrease the symptoms of the side effects. Results: It will be assessed on the basis of improvement
in subjective and objective criteria. Benefits: Project will help us to resolve the research question.
There may not be any benefit for the society at this stage of the research, but future generations are
likely to be benefited as to find out proper treatment protocol for the management of
Shushkaakshipaka (Dry Eye Disease). Collected information from this research project will be kept
confidential, all outcomes will be noted in tabular form and appropriate statistical tests will be
applied to compare the effect. |