| CTRI Number |
CTRI/2023/08/056440 [Registered on: 11/08/2023] Trial Registered Prospectively |
| Last Modified On: |
02/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Mudgaparni Siddha Ghrita Tarpan In Dry Eye Syndrome |
|
Scientific Title of Study
|
Open Randomized Controlled Clinical Trial Of Mudgaparni Siddha Ghrita Tarpan In Shushkakshipaka With Special Reference To Dry Eye Syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prerana Prakash Kumbhar |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 2 Netra Rog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal WalWa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8308590005 |
| Fax |
|
| Email |
kumbharprerana1698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Kate |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
2rd Floor Department of Shalakya Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9404701645 |
| Fax |
|
| Email |
dr.sujatakate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Kate |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
2rd Floor Department of Shalakya Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
MAHARASHTRA
416301
India |
| Phone |
9404701645 |
| Fax |
|
| Email |
dr.sujatakate@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Prerana Prakash Kumbhar |
| Address |
OPD no 2 Netra Rog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli |
| 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 Prerana Prakash Kumbhar |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
OPD no 2 Netra Rog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
8308590005
kumbharprerana1698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Institutional Ethics Committee |
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: shushkakshipaka, (2) ICD-10 Condition:H049||Disorder of lacrimal system, unspecified. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Carboxymethyl Cellulose 0.5 % | Indian Journal of Public Health Research And Developement 2019 vol 10
dosage 1 drop four times a day
Route Ocular
duration 5 days | | 2 | Intervention Arm | Procedure | - | netratarpaNam, नेतà¥à¤°à¤¤à¤°à¥à¤ªà¤£à¤®à¥ | (Procedure Reference: Sharangdhar, Procedure details: once in a day for 5 days)
(1) Medicine Name: Mudgaparni Siddha Ghrita, Reference: Bhavprakash, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 20(ml), Frequency: od, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients suffering from symptoms of shuskakshipak Netrashushkata Daha Gharsha Aavildarshanam krichronmeelanimeelana
2 Patients having excessive outdoor work
3 Patients having software profession those who gets exposed to visual devices very often for longer duration
4 Patients willing to take part in treatment
|
|
| ExclusionCriteria |
| Details |
1 Patient having any congenital eye anomaly
2 Patients having ocular disease or infection
except dry eye
3 Patients with history of ophthalmic surgeries
4 Patients having any autoimmune disorders like RA
or Sjogrens syndrome
5 Patient having any psychological problem leading
to depression |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Mudgaparni siddha ghrit tarpan in the management of shushkakshipaka |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Mudgaparni siddha ghrit tarpan & Carboxymethyl cellulose 0.5 percent eye drop in the management of shushkakshipaka |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
30/08/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As we see the number of patients with dry eye syndrome are increasing now a days so this study will help the patients to relieve the symptoms and gives strength to the eyes This study is open randomized controlled clinical trial in which mudgaparni siddha ghrita is a trial drug for tarpana . Procedure will be done once in a day for 5 days. Carboxy methyl cellulose 0.5 % eye drops is a control drug will be given as 1 drop for 4 times a day in shushkakshipaka with special reference to dry eye syndrome for 5 days. After 5 days patient is advice to come on 10th and 15th day for follow up. 38 patients in each group will be studied. Study will be conducted in India. Outcome of study will be assessed on basis of Shirmers test and reduction of signs and symptoms of dry eye syndrome will be noted. |