| CTRI Number |
CTRI/2024/03/064542 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the roll of Rajanyadi Ksheerpaka Parisheka kriyakalp in treatment of patients with dryness of eyes as symptom in comparison with regularly used Carboxymethylcellulose Eye Drops. |
|
Scientific Title of Study
|
A Randomized Controlled Trial of effectiveness of Rajanyadi Ksheerpaka Parisheka in comparison with Carboxymethylcellulose Eye Drops in the management of Shushkakshipaka (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 Anjali Shelke |
| Designation |
PG Scholar |
| Affiliation |
YMT Ayurvedic Medical College And Hospital |
| Address |
YMT Ayurvedic Medical College and Hospital ,Shalakya Tantra Department, Ground Floor, Institutional Area, Sector 4, Kharghar, Navi Mumbai, Raigarh, Maharashtra
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8275466710 |
| Fax |
|
| Email |
anjali09.shelke@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit Ghadge |
| Designation |
Associate Professor |
| Affiliation |
YMT Ayurvedic Medical College And Hospital |
| Address |
YMT Ayurvedic Medical College and Hospital ,Shalakya Tantra Department, Ground Floor, Institutional Area, Sector 4, Kharghar, Navi Mumbai, Raigarh, Maharashtra
Ratnagiri
MAHARASHTRA
410210
India |
| Phone |
9028435553 |
| Fax |
|
| Email |
dr.abhijit88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijit Ghadge |
| Designation |
Associate Professor |
| Affiliation |
YMT Ayurvedic Medical College And Hospital |
| Address |
YMT Ayurvedic Medical College and Hospital ,Shalakya Tantra Department, Ground Floor, Institutional Area, Sector 4, Kharghar, Navi Mumbai, Raigarh, Maharashtra
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9028435553 |
| Fax |
|
| Email |
dr.abhijit88@gmail.com |
|
|
Source of Monetary or Material Support
|
| YMT Ayurvedic Medical College and Hospital Sector 4 Kharghar Raigarh Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Anjali Shelke |
| Address |
Parijat Bunglow, near Agatya Hotel, Pune- Nashik Highway, a/p- Alephata,Tal- Junnar, Dist- Pune 412411 |
| Type of Sponsor |
Other [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 Anjali Shelke |
YMT Ayurvedic Medical College and Hospital |
OPD and IPD of Shalakyatantra Department, YMT Ayurvedic Hospital, Institutional Area, Sector 4, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA |
8275466710
anjali09.shelke@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:H048||Other disorders of lacrimal system. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: Sharangdhar Samhita Uttartantra Adhyay13 shlok no2-7, Procedure details: Parisheka will be performed in supine position and ask patient to close the Eyes.
Now the fresh prepared ksheerpaka made by above mentioned procedure will be poured on the closed eyes from the height of 4 angulis (1 angul approx. 1.95 cm ; 4 angul approx. 7.8 cm).
According to Sharangdhar, Ropan parisheka will be performed for 400 matra kaal ( 1 matra kaal = 1 Nimesh= 1.46 sec ; 400 X 1.46= 584 sec ( 9.7 min- approx. 10 minutes).
The quantity of ksheerpaka will be 500 ml with approx. 1.5- 2mm)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Carboxymethylcellulose Eye Drops | 1 drop 4 times a day in each eye will be instilled for 6 days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient suffering from symptoms of Shushkakshipaka (Netrashushkata, Netra
Toda, Vilokane cha Avildarshanam, Gharsha, etc.)
2. Patients age group between 30-50 years irrespective of gender, economical status.
3. Patients with 5 mm- 15 mm on Schirmer’s I test.
|
|
| ExclusionCriteria |
| Details |
1. Patients having any ocular infection.
2. Patients having any congenital eye anomaly.
3. Patients having any systemic disorder like diabetes mellitus, hypertension and
autoimmune disorders like Sjogren’s syndrome etc.
4. Patients having any corneal pathology.
5. Patients having congenital absence of meibomian glands and other lid disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rajanyadi Ksheerpaka Parisheka is significantly effective in the treatment of Shushkakshipaka (Dry Eye Syndrome) than Carboxymethylcellulose Eye Drops |
follow up on Day 0th, 3rd,7th,14th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rajanyadi Ksheerpaka Parisheka is not effective in the treatment of Shushkakshipaka (Dry Eye Syndrome) than Carboxymethylcellulose Eye Drops |
follow up on Day 0th, 3rd,7th,14th |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/04/2024 |
| 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 Trial of effectiveness of Rajanyadi Ksheerpaka Parisheka in comparison with Carboxymethylcellulose Eye Drops in the management of Shushkakshipaka (Dry Eye Syndrome).
Assessment Criteria: Selected patients will be treated with Rajanyadi Ksheerpaka Parisheka and grades of symptoms will be noted in each follow up and compared to initial values.
Subjective criteria: 1. Ruksha vartma grade0 / 1 (Absent/ Present) 2. Vilokane cha avil darshanam grade0/ 1 (Absent /Present) 3. photophobia grade 0 /1 (Absent /Present) 4. Gharsha grade0 /1 (Absent /Present) 5. Redness grade0 /1 (Absent /Present) 6. Toda (Pricking Pain) grade0 /1 (Absent /Present)
Objective criteria: Visual acuity assessed by Snellen’s chart Dryness of eyes to be assessed by Shirmer’s test, Rose Bengal test, Tear Film break up test
|