| CTRI Number |
CTRI/2024/05/067084 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment for dry eye disease in post menopausal women. |
|
Scientific Title of Study
|
A comparative clinical trial to assess combined effect of drakshadi ghrita aschyotana and shatavari ksheera paka paana internally versus shatavari ksheera paka internally in post menopausal women with 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 Anita B Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
BVVS AYurved Medical College and Hospital Bagalkot |
| Address |
Department of Shalakya tantra BVVS Ayurved Medical College &and Hospital Bagalkot
Bagalkot
KARNATAKA
587101
India |
| Phone |
8050867308 |
| Fax |
|
| Email |
dranitayu79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita B Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
BVVS AYurved Medical College and Hospital Bagalkot |
| Address |
Department of Shalakya tantra BVVS Ayurved Medical College &and Hospital Bagalkot
KARNATAKA
587101
India |
| Phone |
8050867308 |
| Fax |
|
| Email |
dranitayu79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita B Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
BVVS AYurved Medical College and Hospital Bagalkot |
| Address |
Department of Shalakya tantra BVVS Ayurved Medical College &and Hospital Bagalkot
KARNATAKA
587101
India |
| Phone |
8050867308 |
| Fax |
|
| Email |
dranitayu79@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences, 4th T Block, Jayanagar, Bengaluru, Karnataka, India - 560041 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of health sciences |
| Address |
4 T Block Jayanagar Bengaluru Karnataka India 560041 |
| Type of Sponsor |
Government funding agency |
|
|
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 Anita B Kulkarni |
BVVS Ayurved Hospital Bagalkot |
OPD No. 8 Shalakya tantra OPD BVVS Ayurveda Hospital, Old BVVS Campus Raichur Road Bagalkot
Bagalkot
KARNATAKA |
8050867308
dranitayu79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| "Instituitional Ethics Committee" |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H041||Other disorders of lacrimal gland. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Drakshadi Ghrita and Shatavari Ksheerapaka , Reference: Astanga Hridaya , Route: Ocular, Dosage Form: Ghrita, Dose: 10(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatavari Ksheerapaka , Reference: Astanga Hridaya , Route: Oral, Dosage Form: Ksheerpaka, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1) Women with complaints of Dry eye disease aged in between 45 -55 years with
menstrual cessation for at least one year.
2) Menopausal Women with Dry eye disease complaints who are willing to participate
in the study |
|
| ExclusionCriteria |
| Details |
a. Women below 45 years.
b. Recurrent eye inflammation.
c. History of trauma.
d. History of eye surgery within three months
e. Systemic illness including DM, HTN, PCOS
f. Malignancy, Psychiatric diseases other uro-genital diseases.
g. Women underwent surgical management for complete hysterectomy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stability of the pre corneal tear film improves, Lubricates the occular surface hence reducing the symptoms of dry eye disease |
0th day, 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing the symptoms of dry eye disease - Grittiness, Blurred vision, Eye strain & increased light tolerance |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/05/2024 |
| 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)
|
Open to Recruitment |
| 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
|
Menopause is common natural transition phase in women’s life in which the body greatly reduces oestogen synthesis which causes dry eyes along with other psychosomatic disturbances. This accounts up to 52% of menopausal women. The DRY EYE DISEASE is multi factorial ocular surface disorder usually caused by chronic inflammation and characterized by tear film instability and increased osmolarity. According to Ayurveda, DRY EYE DISEASE can be correlated with Shushkakshipaka, a Vata-Pittaja pradhana Sarvagata netra roga. Drakshadi ghrita aschyotana and Shatavari ksheerapaka paana will be administered to the selected participants. The observations before and after the treatment will be compared and assessed using OSDI scoring for Dry eye diseaseand Schirmer’s test, TBUT and Serum Oestrogen level. Then results will be statistically analyzed So effect of these medicines is expected to give encouraging results by jeevaneeya and chakshusya effects. Having phyto oestrogen, also helps in regulation of oestrogen in general thus helping the reversal of Dry eye disease in post menopausal women. The study can show new vista in the management of post menopausal Dry eye disease by offering safe, effective affordable treatment. |