| CTRI Number |
CTRI/2024/07/070986 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy of punarnavadi eye drops instillation and rasnadi taila nasal drops in the management of pain,itching and watering in eyes |
|
Scientific Title of Study
|
An open labelled randomized controlled clinical study to evaluate the efficacy of punarnavadi eye drops with rasnadi taila nasya in the management of vataja abhishyanda with special reference to allergic conjunctivitis |
| 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 Nishu Yadav |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 406, Department of Shalakya Tantra,
Parul University, Limda,
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
09996339556 |
| Fax |
|
| Email |
drnishu9595@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivkant Sharma |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 406, Department of Shalakya Tantra,
Parul University, Limda,
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9124927283 |
| Fax |
|
| Email |
shivkants@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivkant Sharma |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 406, Department of Shalakya Tantra,
Parul University, Limda,
Vadodara
GUJARAT
391760
India |
| Phone |
9124927283 |
| Fax |
|
| Email |
shivkants@ymail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved, Parul University, Vadodara, Gujarat, 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul University, Vadodara,
Gujarat, 391760 |
| 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 Nishu Yadav |
Parul Ayurved Hospital |
OPD No 108, Shalakya Tantra OPD, Parul Ayurved Hospital, Parul University Dr Nishu Yadav PO Limda Tal Waghodia Vadodara 391760
Vadodara
GUJARAT |
9996339556
drnishu9595@gmail.comOPD |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituttional Ethics Committee- Parul Institute of Ayurved, Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: vataj abhishyanda, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Azelastine eye drops (0.05%) | Generic name - Azelastine hydrochloride
Dosage form - Ophthalmic solution
Drug class - Ophthalmic antihistamines and decongestants
Dose - 1drop(QID) | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Punarnavadi eye drops, Reference: Yogratnakar,page no.778, Route: Ocular, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: 14 Days, Duration: , anupAna/sahapAna: No, Additional Information: | | 3 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: sharangdhar uttartantra 8/38, Procedure details: Before giving nasal drops to patients -Patient made to lie down and with head end tilted upwards -followed by mild fomentation -raise the tip of the nose and instill lukewarm rasnadi nasya taila in each nostril -Followed by mild sudation of the facial area -Guide the patient not to swallow the medicine, instead spit it repeatedly)
(1) Medicine Name: Rasnadi taila nasya, Reference: Astangsangrah uttartantra, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients presenting with the signs and symptoms of Vataja Abhishyanda will be selected.
2 Patients irrespective of gender, religion and socio-economic status will be included in study. |
|
| ExclusionCriteria |
| Details |
1 Patients not willing to participate in the study.
2 severe cases of conjunctivitis with complications like corneal ulcers, trachoma,dacryocystitis etc.
3 eye associated with any other inflammatory and infective ocular conditions.
4 patients with known case of hypertension,diabetes mellitus,and any major systemic illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To cure vataja abhishyanda (allergic conjunctivitis) |
15th day and 21th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To cure allergic conjunctivitis |
15th day and 21th day. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
12/08/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Allergic conjunctivitis is often under diagnosed and consequently under treated. Simple allergic conjunctivitis is the most common form of ocular allergy having prevalence rate 5–22 % . It is a hypersensitivity reaction to specific airborne antigens. Cases of Vataja Abhishyanda (Allergic Conjunctivitis) is frequently seen in OPD of Shalakya tantra on a routine basis. There is a need to develop a therapy that is without side effect and less expensive. In the study an attempt is made to compare the effect of Punarnavadi eye drops and Rasnadi taila nasya with Azelastine eye drops(0.05%) in order to get over these challenges and make ayurvedic procedures more patients - friendly. Many patients are unable to visit the hospital for a fairly straightforward procedure due to a fast- paced lifestyle, hectic working hours, as well as other unavoidable factors. The purpose of the study is to compare the Punarnavadi eye drops with Rasnadi taila nasya and Azelastine eye drops (0.05%), in Vataja Abhishyanda with special reference to Allergic conjunctivitis |