| CTRI Number |
CTRI/2024/12/078171 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the difference between eye drops using Yashtimadhu Ghrita along with Panchtikta Kshir Basti and eye drops using Yashtimadhu Ghrita with ChakshusyaBasti in dry eye due to osteoarthritis |
|
Scientific Title of Study
|
Evaluation of Comparative efficacy of Yastimadhu Ghrita eye drops along with Panchtikta Kshira Basti versus Yastimadhu Ghrita eye drops and Chakshusya Basti in the management ofdry eye Syndrom Associated Osteoarthritis A Pilot Study |
| 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 Roshna Bhutada |
| Designation |
Professor |
| Affiliation |
Mahatama Gandhi Ayurved College Hospital And Research Centre |
| Address |
Room No 45 Department of Shalakya Tantra Mahatama Gandhi Ayurved College Hospital And Research Centre
Room No 45 Department of Shalakya Tantra Mahatama Gandhi Ayurved College Hospital And Research Centre
Wardha
MAHARASHTRA
442001
India |
| Phone |
8766866422 |
| Fax |
|
| Email |
roshana.bhutada@dmiher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roshna Bhutada |
| Designation |
Professor |
| Affiliation |
Mahatama Gandhi Ayurved College Hospital And Research Centre |
| Address |
Room No 45 Department of Shalakya Tantra Mahatama Gandhi Ayurved College Hospital And Research Centre
Room No 45 Department of Shalakya Tantra Mahatama Gandhi Ayurved College Hospital And Research Centre
Wardha
MAHARASHTRA
442001
India |
| Phone |
8766866422 |
| Fax |
|
| Email |
roshana.bhutada@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Parwe |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Center |
| Address |
Room No 45 Department of Panchakarma Mahatama Gandhi Ayurved College Hospital And Research Centre
Room No 45 Department of Panchakarma Mahatama Gandhi Ayurved College Hospital And Research Centre
Wardha
MAHARASHTRA
442001
India |
| Phone |
9511659185 |
| Fax |
|
| Email |
shweta.parwe@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahatama Gandhi Ayurved College Hospital And Research Centre Salod Wardha Maharashtra India 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
| Address |
Room No 45 Mahatama Gandhi Ayurved College Hospital And Research Centre Salod Wardha Maharashtra |
| 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 Roshna bhutada |
Mahatama Gandhi Ayurved College Hospital And Research Centre |
Room No 45 Department of Shalakya Tantra Mahatama Gandhi Ayurved College Hospital And Research Centre
Wardha
MAHARASHTRA |
8766866422
roshana.bhutada@dmiher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H04||Disorders of lacrimal system. Ayurveda Condition: SUSHK, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: , Procedure details: Panchatikta Ksheer basti will be administered for eight days & parihara kala will be given for next eight days. Aschyotan with Yashtimadhu ghrit 10 drops each eye will be administered for 100 matra kala daily for eight days.
)
| | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: , Procedure details: Chakshushya basti will be administered for eight days & parihara kala will be given for next eight days. Aschyotan with Yashtimadhu ghrit 10 drops each eye will be administered for 100 matra kala daily for eight days.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to do Procedure were included consent of patient to do Procedure Age group 45 to 70 years Both sexes Patients with controlled hypertension up to normal to 140/90 mm of hg
Controlled Diabetes mellitus patients Range 100 to 160 with medication Patient with BMI up to 30
|
|
| ExclusionCriteria |
| Details |
Uncontrolled HT and DM Traumatic arthritis Post cataract surgery up to 1 year
knee joint replaced Contraindicated for basti and Aschyotan
Dry eyes not associated with OA example dry eye due to Graves disease Hashimotos disease primary and secondary Sjogrens syndrome
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To access the efficacy of eye drops along with PanchtiktaKshirBasti versus eye drops and ChakshusyaBasti over Visual acuity Schirmer’s test Tear film breakup time Womac scale Pain Walking Physical Function
range of Motion |
24 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison and assessment of efficacy of eye drops along with PanchtiktaKshirBasti versus eye drops and ChakshusyaBasti in Visual acuity Schirmer’s test Tear film breakup time Womac scale Pain Walking Physical Function range of Motion |
3 week 3 days |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/12/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
the volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Before the study approval has been taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done.After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a parallel group, randomized, open clinical, standard controlled trial. it will include a 24 days treatment period and at 48th day follow up period |