| CTRI Number |
CTRI/2022/10/046469 [Registered on: 13/10/2022] Trial Registered Prospectively |
| Last Modified On: |
06/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Jalaukavcharan and Amoxicillin 500mg and Clavulanic acid 125mg in Nasur with special referance to Acute Dacryocystitis |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial Of Jalaukavacharan and Amoxicillin 500mg and Clavulanic acid 125mg In Puyalas With Special Reference to Acute Dacryocystitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Baliram Bhagile |
| Designation |
Pg Scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
OPD NO- 13 Department of Shalakyatantra Vidarbha Ayurved Mahavidyalaya Chhatri talao road near farshi stop Amravati
Amravati
MAHARASHTRA
444601
India |
| Phone |
7030084201 |
| Fax |
|
| Email |
swatibhagile9936@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Devendra R Chaudhari |
| Designation |
Guide and Associate Professor Department of Shalakyatantra |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
Vidarbha Ayurved Mahavidyalaya Chhatri talao road near farshi stop Amravati
Amravati
MAHARASHTRA
444601
India |
| Phone |
8208501419 |
| Fax |
|
| Email |
Chaudharidevendra5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Devendra R Chaudhari |
| Designation |
Guide and Associate Professor Department of Shalakyatantra |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
Vidarbha Ayurved Mahavidyalaya Chhatri talao road near farshi stop Amravati
Amravati
MAHARASHTRA
444601
India |
| Phone |
8208501419 |
| Fax |
|
| Email |
Chaudharidevendra5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidarbha Ayurved Mahavidyalaya Amravati |
|
|
Primary Sponsor
|
| Name |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
Chhatri talao road near farshi stop Amravati |
| 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 |
| Swati Baliram Bhagile |
Vidarbha Aturved Mahavidyalaya and Hospital Amravati |
OPD no 13 Department of Shalakyatantra Vidarbha Ayurved Mahavidyalaya Hospital Chhatri talao road near farshi stop Amravati
Amravati
MAHARASHTRA |
7030084201
swatibhagile9936@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S H V P M Vidarbha Ayurved Mahavidyalaya Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H049||Disorder of lacrimal system, unspecified. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | | (Procedure Reference: Sushrut Samhita, Procedure details: The no of leeches to be applied varies according to severity of the condition. If the leech does not stuck, then it is applied after making puncture by sterile needle. Even after this if it is does not stuck, another leech is tried. The leech sucks blood by its anterior sucker which is attached to the base by posterior sucker. Jalaukavcharan was done 1,3 and 5 day as per required. )
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amoxicillin 500mg and Clavulanic acid 125mg, Reference: Kanskis Clinical Opthalmology, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 625(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients having classical sign and symptoms of Puyalasa
2 patient will be selected irrespective of sex religion occupation
|
|
| ExclusionCriteria |
| Details |
1 Patient with congenital Dacryocystitis
2 Patient with other occular disease
3 Recently operated patients
4 Patients with other systemic disorder like DM HTN |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Uttamupashaya- 75-100%
Madhyanupashaya- 50-74%
Alpaupashaya- 25-49%
Anupashaya- less than 25% |
0th day
3rd day
5th day
15th day
30th day
60th day
90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Remission in symptoms of Epiphora
Remission in redness at medial canthus
Remission in Acute Dacryocystitis |
7th day
14th day
30th day
75th day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/10/2022 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Randomized clinical trial will be conducted to study the effect of Jalaukavcharan in Puyalasa with special referance to Acute dcryocystitis. Trial will be conducted in our institute. Total 60 patients with inclusive criteria having sign and symptomps of Puyalasa will be selected and will be divided in two groups. One group will be advised Jalaukavcharan and other will be advised Amoxicillin 500mg and Clavulanic acid 125 mg.And result will be compared. Primary outcome will be about Evaluation of Puyalasa and secondary outcome will be about assesssment criteria of effect of Jalaukavcharan. And results will be noted. |