| CTRI Number |
CTRI/2021/09/036976 [Registered on: 29/09/2021] Trial Registered Prospectively |
| Last Modified On: |
28/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Akshitarpana] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Yashtimadhu-Siddha Ghrita Akshitarpana in Dry Eye |
|
Scientific Title of Study
|
Study on the efficacy of Yashtimadhu-Siddha Ghrita Akshitarpana in Shushkakshipaka w.s.r to Dry Eye |
| Trial Acronym |
YSG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dharmendra Prasad |
| Designation |
MS (Ay) SCHOLAR |
| Affiliation |
Govt.Ayurvedic College and Hospital,Patna |
| Address |
Govt Ayurvedic College and Hospital Kadamkuan patna Bihar
Patna
BIHAR
800003
India |
| Phone |
8298510230 |
| Fax |
|
| Email |
prasaddharmendra19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Kumari Uma Pandey |
| Designation |
Prof and HOD of Shalakya |
| Affiliation |
Govt.Ayurvedic College and Hospital Patna |
| Address |
Department of Shalakya
Govt Ayurvedic College and Hospital Kadamkuan patna Bihar
Patna
BIHAR
800003
India |
| Phone |
9431646285 |
| Fax |
|
| Email |
dr.kumariuma@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prof Kumari Uma Pandey |
| Designation |
Prof and HOD of Shalakya |
| Affiliation |
Govt.Ayurvedic College and Hospital Patna |
| Address |
Department of Shalakya
Govt Ayurvedic College and Hospital Kadamkuan patna Bihar
Patna
BIHAR
800003
India |
| Phone |
9431646285 |
| Fax |
|
| Email |
dr.kumariuma@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Govt Ayurvedic College, Patna |
|
|
Primary Sponsor
|
| Name |
Govt Ayurvedic College and Hospital Kadamkuan Patna |
| Address |
Govt Ayurvedic College and Hospital Kadamkuan patna Bihar |
| Type of Sponsor |
Government medical college |
|
|
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 Dharmendra Prasad |
Government Ayurvedic College and Hospital, Patna |
Government Ayurvedic College and Hospital
Patna
BIHAR |
8298510230
prasaddharmendra19@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:H00-H59||Diseases of the eye and adnexa. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Akshitarpana | (Procedure Reference: Sushruta Samhita Uttaratantra 6/26, Procedure details: Akshitarpana (Retaining medicated ghee in the eyes))
(1) Medicine Name: Yashtimadhu Siddha Ghrita, Reference: Sarangdhara Samhita Madhyamkhanda 9, Route: Ocular, Dosage Form: Ghrita, Dose: 30(g), Frequency: od, Duration: 2 Months | | 2 | Comparator Arm | Procedure | - | Akshitarpana | (Procedure Reference: Sushruta Samhita Uttaratantra 6/26, Procedure details: Akshitarpana (Retaining of medicated ghee in the eyes))
(1) Medicine Name: Go-ghrita, Reference: Sarangdhara Samhita Madhyamkhand 9, Route: Ocular, Dosage Form: Ghrita, Dose: 30(g), Frequency: od, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with the classical features of shushkakshipaka as well as symptoms suggestive of dry eye syndrome |
|
| ExclusionCriteria |
| Details |
Age less than 25 years and more than 60 years, pregnancy, patient having symptoms of perforated corneal ulcer, uveitis, glaucoma, acute conjunctivitis, systemic metabolic disease causing dry eye syndrome patient with impaired eyelid function. patient with occular surgery prior to three month of study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms of Shushkakshipaka |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement insymptoms of Shushkakshipaka |
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/10/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In Sushruta Samhita, Shushkashipaka is described with the clinical features like burning sensation, irritation, strain, redness in the eyes along with blurring of vision and headache which are similar to that of Dry eye. It is a multifactorial disorder due to inflammation of ocular surface and lacrimal gland, neurotrophic deficiency and meibomian gland dysfunction. Due to wide spectrum of disease and much prevalence in the society, this disease is selected for the comparative study using Yashtimadhu siddha ghrita and go-ghrita for Akshitarpana. |