| CTRI Number |
CTRI/2023/06/053572 [Registered on: 06/06/2023] Trial Registered Prospectively |
| Last Modified On: |
05/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of yastimadhu siddha ghrita nasal drop instillation on Dry eye disease. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study of Yastimadhu Siddha Ghrita Pratimarsha Nasya on Dry Eye Disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rebecca Irom |
| Designation |
MS Scholar Shalakya tantra |
| Affiliation |
Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital |
| Address |
Department of Shalakya Tantra,Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital, Satara Road, pune 43
Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital, Satara Road, pune 43
Pune
MAHARASHTRA
411043
India |
| Phone |
9863132583 |
| Fax |
|
| Email |
beccairom20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Santosh Mulik |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital |
| Address |
Department of Shalakya Tantra,Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital, Satara Road, pune 43
Pune
MAHARASHTRA
411043
India |
| Phone |
9175382645 |
| Fax |
|
| Email |
saritamulik9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rebecca Irom |
| Designation |
MS Scholar Shalakya tantra |
| Affiliation |
Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital |
| Address |
Department of Shalakya Tantra,Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital, Satara Road, pune 43
Pune
MAHARASHTRA
411043
India |
| Phone |
9863132583 |
| Fax |
|
| Email |
beccairom20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital, Pune-43 |
|
|
Primary Sponsor
|
| Name |
Dr. Rebecca Irom |
| Address |
Department of Shalakya Tantra, Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital |
| Type of Sponsor |
Other [Self] |
|
|
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 Rebecca Irom |
Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital,Pune. |
Department of Shalakya Tantra, Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital, Satara Road, Pune
Pune
MAHARASHTRA |
9863132583
beccairom20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BV(DU)COA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H048||Other disorders of lacrimal system. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Carboxymethyl cellulose 0.5 % eye drop | It is a lubricating eye drop used to relieve dry eye disease.
Dose- 1 drop TDS in both eyes Duration- 15 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu siddha ghrita, Reference: Sushruta samhita, uttara tantra 15 / 21-22, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
patients suffering from mild to moderate symptoms of dry eye disease who are willing to participate in the study will be selected |
|
| ExclusionCriteria |
| Details |
Patients showing severe symptoms of dry eye, any ocular surface pathology, any acute nasal pathology, having congenital anomalies of eye, who are one eyed patient and those whose age are below 10 yrs and above 45 yrs will be excluded. |
|
|
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 |
| TFBUT test value to increase by 2-3 secs. Schirmer-I test value to increase by 1-2 units (1mm-2mm) |
28 days study with 3 follow up (7th day,14th day & 28th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of dryness, redness or congestion, itching, burning sensation & eye fatigue. |
28 days study with 3 follow up (7th day,14th day & 28th day) |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
14/06/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomized controlled clinical study of yastimadhu siddha ghrita pratimarsha nasya will be done on 63 patients presenting with complaints of Dry eye disease and they will be divided into 3 groups (A, B & C) . Group A will be provided with the trial drug, yastimadhu siddha ghrita and will be advised to instill 2 drops in each nostril every morning for 15 days. Group C will be provided with the control drug, Carboxymethylcellulose 0.5% eyedrop and will be advised to instill one drop three times a day for 15 days. Group B will be provided with both the drugs and will be advised the same. Study will be conducted for 28 days and all observations will be taken & recorded starting from 0th day and follow up will be done on 7th and14th day & on the 28th day observations will be taken for any recurrences. Data recorded will be analized statistically and conclusion will be drawn based on it. |