| CTRI Number |
CTRI/2025/07/089929 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Jeevaniya dravya sidhha ghrita nasya and netratarpan in comparison with lubricant eyedrops in dry eye disease |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial of Jeevaniya Dravya siddha Ghrita Nasya
and Netratarpan in comparison with Carboxymethyl Cellulose (0.5%) eyedrops in Shushkakshipaka with special reference to Dry Eye Disease. |
| 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 Adarsh Ramkalap Sharma |
| Designation |
Phd Scholar and Assistant Professor |
| Affiliation |
Ayurved Mahavidyalaya Sion, Maharashtra University of Health Sciences |
| Address |
A11, Nair wadi, Makharia compound, Kherani road, Sakinaka, Mumbai-400072
Mumbai (Suburban)
MAHARASHTRA
400072
India |
| Phone |
8082229002 |
| Fax |
|
| Email |
sharmaadarsh808@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravidas Wamanrao More |
| Designation |
Incharge Principal, Professor, HOD (Department of Shalakyatantra) |
| Affiliation |
Ayurved Mahavidyalaya Sion, Maharashtra University of Health Sciences |
| Address |
Principal cabin, 1st floor, main building, Ayurved Vidya Prasarak Mandals Ayurved Mahavidyalaya, near Sion Railway Station, Sion (E), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9967483930 |
| Fax |
|
| Email |
ravimore67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adarsh Ramkalap Sharma |
| Designation |
Phd Scholar and Assistant Professor |
| Affiliation |
Ayurved Mahavidyalaya Sion, Maharashtra University of Health Sciences |
| Address |
A11, Nair wadi, Makharia compound, Kherani road, Sakinaka, Mumbai-400072
Mumbai (Suburban)
MAHARASHTRA
400072
India |
| Phone |
8082229002 |
| Fax |
|
| Email |
sharmaadarsh808@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Vidya Prasarak Mandals Ayurveda Mahavidyalaya, near Sion Railway Station, Sion (E), Mumbai 400022, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Ayurved Vidya Prasarak Mandals Ayurved Mahavidyalaya Sion |
| Address |
Phd section, Ayurved Vidya Prasarak Mandals Ayurved Mahavidyalaya, near Sion Railway Station, Sion(E), Mumbai 400022, Maharashtra, India |
| 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 ADARSH RAMKALAP SHARMA |
APMs Ayurved Mahavidyalaya, Sion, Mumbai |
OPD and IPD of Shalakyatantra department, Main building, APMs Ayurved Mahavidyalaya, near Sion Railway Station,Mumbai-400022
Mumbai (Suburban)
MAHARASHTRA |
08082229002
sharmaadarsh808@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: JEEVANIYA DRAVYA SIIDHA GHRITA, Reference: Sushrut uttartantra 9/21, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 8(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: NASYA AND NETRATARPANA WITH ABOVE CLASSICAL FORMULATION IN MORNING TIME | | 2 | Comparator Arm (Non Ayurveda) | | - | Carboxy methyl cellulose | lubricant drop used in dry eye disease concentration 0.5% |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients showing symptoms of Shushkakshipaka (Dry Eye Syndrome)
2. Patients with dryness of eyes with or without pain/pricking sensation, photophobia, and mild redness, less flow of tears, foreign body sensation, scratchy sandy feeling and itching.
3. Patients with score less than 15mm on Schirmer’s test |
|
| ExclusionCriteria |
| Details |
1. Age below 30 years and above 70years
2. Patients having corneal ulcers.
3. Patients having congenital absence of meibomian glands.
4. Patients having other eye diseases.
5. Patients having systemic diseases like uncontrolled diabetes mellitus, hypertension.
6. Patients having ocular infections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Jeevaniya dravya siddha ghrita Nasya with Netratarpan is significantly effective than carboxy methyl cellulose (o.5%) eye drops in the management of Shushkakshipaka 9Dry Eye Syndrome). |
follow up on 0th, 7th, 14th, 21st, 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Jeevaniya dravya siddha ghrita Nasya with Netratarpan is not effective than carboxy methyl cellulose (o.5%) eye drops in the management of Shushkakshipaka 9Dry Eye Syndrome). |
follow up on 0th, 7th, 14th, 21st, 42nd day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/09/2025 |
| 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="2"
Months="0"
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
|
TITLE A Randomized Controlled Clinical Trial of Jeevaniya Dravya siddha Ghrita Nasya and Netratarpan in comparison with Carboxymethyl Cellulose (0.5%) eyedrops in Shushkakshipaka with special reference to Dry Eye Disease
ASSESSMENT CRITERIA: Selected patients will be treated with Jeevaniya Dravya Siddha Ghrit Nasya Netratarpan and Carboxy methyl cellulose eyedrops, grades of symptoms will be noted in each follow-up and compared to initial values. Subjective criteria: 1. Ruksha vartma grade 0 / 1 (Absent/ Present) 2. photophobia grade 0 /1 (Absent /Present) 3. Gharsha grade0 /1 (Absent /Present) 4. Redness grade0 /1 (Absent /Present) 5. Toda (Pricking Pain) grade0 /1 (Absent /Present) Objective criteria: 1.Visual acuity assessed by Snellen’s chart 2. Dryness of eyes to be assessed by Schirmer’s test, Rose Bengal test, Tear Film break up test. |