| CTRI Number |
CTRI/2025/03/081630 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Evaluate the effect of Shigruadi Aschyotan (Eye drops) in the management of Kaphaja Abhishyanda w.s.r. to Seasonal Allergic Conjuctivitis. |
|
Scientific Title of Study
|
A Clinical study to evaluate the effect of Shigruadi Aschyotan (Eye drops) in the management of Kaphaja Abhishyanda w.s.r. to Seasonal Allergic Conjuctivitis. |
| 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 SukhDev Singh |
| Designation |
Professor |
| Affiliation |
R.G.G.P.G Ayurvedic College and Hospital |
| Address |
Department of Shalakya Tantra R.G.G.P.G Ayurvedic college and hospital paprola kangra (H.P) 176115
R.G.G.P.G Ayurvedic college and hospital paprola kangra (H.P) 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
09418471230 |
| Fax |
|
| Email |
drsukhdev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiwali verma |
| Designation |
Pg scholar |
| Affiliation |
R.G.G.P.G Ayurvedic College and Hospital |
| Address |
Department of Shalakya Tantra R.G.G.P.G Ayurvedic college and hospital paprola kangra (H.P) 176115
R.G.G.P.G Ayurvedic college and hospital paprola kangra (H.P) 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8988326521 |
| Fax |
|
| Email |
shiwaliv1441@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SukhDev Singh |
| Designation |
Professor |
| Affiliation |
R.G.G.P.G Ayurvedic College and Hospital |
| Address |
Department of Shalakya Tantra R.G.G.P.G Ayurvedic college and hospital paprola kangra (H.P) 176115
R.G.G.P.G Ayurvedic college and hospital paprola kangra (H.P) 176115
HIMACHAL PRADESH
176115
India |
| Phone |
09418471230 |
| Fax |
|
| Email |
drsukhdev@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, R.G.G.P.G Ayurvedic College and Hospital Paprola,Distt.Kangra, H.P.,176115 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt post Graduate Ayurvedic College and Hospital,Paprola |
| Address |
Rajiv Gandhi Govt post Graduate Ayurvedic College and Hospital,Paprola |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sukhdev Singh |
Rajiv Gandhi Govt Ayurvedic college and Hospital , Paprola |
OPD NO 219, Department of Shalakya Tantra
R.G.G.P.G Ayurvedic college and hospital paprola kangra (H.P) 176115
Department of Shalakya Tantra
R.G.G.P.G Ayurvedic college and hospital paprola kangra (H.P) 176115
Kangra
HIMACHAL PRADESH |
9418471230
drsukhdev@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola ,Distt Kangra,H.P, 176115, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: ABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | AScyotanam, आश्च्योतनम् | (Procedure Reference: Bhaishjya Ratnawali, Procedure details: 1 drop 6 times a day for 7 days)
(1) Medicine Name: shigruadi ascyotanam, Reference: Bhaishjya Ratnawali, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: qid, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | AScyotanam,(Eye drops) | (Phenylephrine0.12%,Naphazoline hydrochloride0.05%,Menthol 0.005%,camphor 0.01% in combination Eye drops)1 drop 6 times a day for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed suffering from Kaphaja Abhishyanda w.s.r Seasonal Allergic Conjunctivitis
Patients willing to undergo trial,Patinets age group 10-70 years |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in study
Patients suffering from blephritis, trichiasis, dacrocystitis ,corneal ulcer and trachoma
Patients suffering from any systemic/ metabolic disorders i.e cardiovascular disease ,diabetes ,hypertension etc |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Seasonal Allergic Conjunctivitis |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of shirgruadi Aschyotan with combination of (Phenylephrine, Naphazoline Hydrochloride, Menthol, Camphor) Eye drops |
7 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
03/04/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I would like to publish my research work after completion of the trial as soon as possible . Patients would be selected from opd /ipd of RGGPG Ayurvedic College and Hospital ,Paprola .2 Groups of 30 Patients will be registered and assesed to evaluate the effect of Shigruadi Aschyotan and combination of phenylephrine ,Naphazoline hydrochloride, Camphor, Menthol as Topical Administration in the management of Kaphaja Abhishyanda w.s.r to Seasonal Allergic Conjunctivits . |