| CTRI Number |
CTRI/2022/02/040490 [Registered on: 22/02/2022] Trial Registered Prospectively |
| Last Modified On: |
18/02/2022 |
| 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 efficacy of Yastimadhu Daruharidra Kwath Aschyotana and opticure eye drop in management of Sirotpat |
|
Scientific Title of Study
|
Randomized controlled clinical trial to study the efficacy of Yastimadhu Daruharidra Kwath Aschyotana and opticure eye drop in the management of Sirotpat |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rekha Munjabhau Mahatme |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurveda Mahavidyalaya, Pune |
| Address |
Dept. of Shalakya Tantra, Second floor, Tilak Ayurveda Mahavidyalaya,583/2, Rasta peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9422711869 |
| Fax |
|
| Email |
rekha12mahatme@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta Salvi |
| Designation |
HOD of Shalakya Tantra Department |
| Affiliation |
Tilak Ayurveda Mahavidyalaya, Pune |
| Address |
Dept. of Shalakya Tantra, Second floor, Tilak Ayurveda Mahavidyalaya,583/2, Rasta peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822082795 |
| Fax |
|
| Email |
salvisangeeta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rekha Munjabhau Mahatme |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurveda Mahavidyalaya, Pune |
| Address |
Dept. of Shalakya Tantra, Second floor, Tilak Ayurveda Mahavidyalaya,583/2, Rasta peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9422711869 |
| Fax |
|
| Email |
rekha12mahatme@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital, Pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya Pune |
| Address |
Tilak Ayurveda Mahavidyalaya, 583/2, Rasta Peth, Pune- 411011 |
| Type of Sponsor |
Private 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 Rekha Munjabhau Mahatme |
Seth Tarachand Ramnath Charitable Ayurved Hospital |
Seth Tarachand Ramnath Charitable Ayurved Hospital opd building first floor opd no 14 Netra opd
580/2,Rasta Peth, Pune
411011
Pune
MAHARASHTRA |
9422711869
rekha12mahatme@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instututional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H102||Other acute conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yastimadhu Daruharidra churna, Reference: Ashtang Sangraha, Route: Ocular, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 10(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: -Yastimadhu Daruharidra kwath Aschyotana 10-12 drops Route of administration local instillation
| | 2 | Comparator Arm (Non Ayurveda) | | - | Opticure eye drop | Opticure eye drop act as Mild antibiotic properties,Astringent effect and gives relief from redness provide cooling effect and soothes eye irritation. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from Sirotpat having at least 3 classical symptoms of sirotpat
1. Redness
2. Sirajaladarshan
3. Daha (burning sensation)
4. Pain |
|
| ExclusionCriteria |
| Details |
1.Patient with episcleritis, corneal injury, corneal ulcer, keratitis, iridocyclitis
2.Immunocompromised patients
3. Patients with contagious diseases, malignancies |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Yastimadhu Daruharidra Kwath Aschyotana and opticure eye drop in the management of Sirotpat |
7 to 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of yastimadhu daruharidra kwath aschyotana and opticure eye drop. |
7to 10 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/03/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We came across number of patient of sirotpat/ simple hyperaemia of conjunctiva in day to day practice. Its incidence is increasing due to use of small screen such as mobile, computers such bright light objects, major air pollutants, poor hygienic condition all these causes are responsible for the hyperaemia of conjunctiva. In modern medicine astringent eye drops is only treatment of hyperaemia. But it gives only symptomatic relief for some days and recurrence of hyperaemia is more so aschyotan is specially used in sirotpat. Aschyotan is more convenient and acceptable mode for local instillation of drug. Yastimadhu churna is madhur rasa and sheeta viryatmak and daruharidra churna is katu tikta rasa and ushna viryatmak. So its action mainly on pitta and rakta dosha. Its decoction having cooling and astringent property. So it constrict the dilated vessels of conjunctiva in simple hyperaemia. In reference to this the study has been undertaken. |