| CTRI Number |
CTRI/2024/12/078136 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
15/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Shatayashti Ghrita Aschyotana i.e Shatavari,Yashtimadhu ,Goghrita In Comparison With Carboxymethylcellulose 0.5 percent Eyedrops In The Treatment Of Dry Eye Syndrome W.S.R To Shushkakshipaka |
|
Scientific Title of Study
|
Effect of Shatayashti Ghrita Aschyotana in comparison with Carboxymethylcellulose 0.5 percent eyedrop in the treatment of Dry Eye Syndrome w.s.r. to Shushkakshipaka in Adults: A Randomized Controlled Trial |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakshanda Satish Akre |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya Nagpur |
| Address |
OPD NO 11 Shalakya tantra department Pakwasa Rugnalaya Shri Ayurved Mahavidyalaya Dhanwantari Marg Hanuman Nagar Nagpur 440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7397840908 |
| Fax |
|
| Email |
rakshandaakre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankita Tripathi |
| Designation |
Assistant professor |
| Affiliation |
Shri Ayurved Mahavidyalaya Nagpur |
| Address |
OPD NO 11 Shalakya tantra department Pakwasa Rugnalaya Shri Ayurved Mahavidyalaya Dhanwantari Marg Hanuman Nagar Nagpur 440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9130093927 |
| Fax |
|
| Email |
ankitaotripathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakshanda Satish Akre |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya Nagpur |
| Address |
OPD NO 11 Shalakya tantra department Pakwasa Rugnalaya Shri Ayurved Mahavidyalaya Dhanwantari Marg Hanuman Nagar Nagpur 440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7397840908 |
| Fax |
|
| Email |
rakshandaakre@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO 11 Shalakya tantra department Pakwasa Rugnalaya Shri Ayurved Mahavidyalaya Dhanwantari Marg Hanuman Nagar Nagpur 440024 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Rakshanda Satish Akre |
| Address |
OPD NO 11 Shalakya tantra department Pakwasa Rugnalaya Shri Ayurved Mahavidyalaya Dhanwantari Marg Hanuman Nagar Nagpur 440024 Maharashtra India |
| 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 Rakshanda Satish Akre |
Shri Ayurved Mahavidyalaya Nagpur |
OPD NO 11 Shalakya tantra department Pakwasa Rugnalaya Shri Ayurved Mahavidyalaya Dhanwantari Marg Hanuman Nagar Nagpur 440024 Maharashtra India
Nagpur
MAHARASHTRA |
7397840908
rakshandaakre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Shri Ayurved Mahavidyalaya Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H045||Stenosis and insufficiency of lacrimal passages. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHATAYASHTI GHRITA ASCHYOTANA , Reference: Yogratnakara , Bhaishajya ratnavali,sharangdhar samhita, Route: Ocular, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | Drug | Other than Classical | | (1) Medicine Name: Carboxymethyl cellulose 0.5% eye drop, Reference: NA, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | Drug | - | | |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having signs & symptoms of digital eye strain.
Patient with Computer vision syndrome.
Patient having age group of 16-50 years irrespective of their sex, caste , economical status & residence status.
Patient willing for treatment.
Patients having normal vision with or without spectacles. |
|
| ExclusionCriteria |
| Details |
Patients not willing for clinical trial.
( Patients suffering from other systemic disorders.
( Patient undergone any intra ocular & extra ocular surgeries.
( Patient having any ocular infectious / inflammatory disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of Shatayashti Ghrita Aschyotana and Carboxymethylcellulose 0.5% eye drop in the treatment of Dry Eye Syndrome.
|
30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Shatayashti Ghrita Aschyotana in the treatment of Computer Vision Syndrome |
At the end of 30 days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 3 |
|
Date of First Enrollment (India)
|
26/12/2024 |
| 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="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
|
A consecutive samples of 68 patients who are seeking treatment and care at the study hospital, who fulfil the eligibility (inclusion and exclusion) criteria and who consent to participant will be selected by convenience sampling method from the study setting (ie. the OPD/Ward/Hospital..). The sample will be then randomly and equally allocated to two groups. The selected sample of 68 subjects will be randomly allocated to two groups using Simple block randomization method. A predetermined, computer generated random allocation plan will be utilised where in 17 blocks of size 4 each will be used for equal assignment of subjects in to two comparison groups.First group will recieve Shatayashti GHRITA ASCHYOTANA and second group will recieve CMC EYEDROP. |