| CTRI Number |
CTRI/2025/02/081100 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic treatment of Amaja Abhishyanda(Acute infective Conjunctivitis) with Punarnavadi eyedrop and Shigrupatradi eyedrop |
|
Scientific Title of Study
|
Efficacy of Punarnavadi eyedrop and Shigrupatradi eyedrop in the management of Amaja Abhishyanda(Acute infective Conjunctivitis)- An Open Labelled Randomised Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nachita |
| Designation |
M.S.Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar, Gujrat |
| Address |
Department of Shalakya Tantra,4th floor ,Institute building, Institute of Teaching and Research in Ayurveda,Jamnagar,Gujarat-361008
Department of Shalakya Tantra,4th floor,Institute building ,Institute of Teaching and Research in Ayurveda,Jamnagar,Gujarat-361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9812280880 |
| Fax |
|
| Email |
nachitay.98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDeepak K Pawar |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar, Gujrat |
| Address |
Department of Shalakya Tantra, Institute of Teaching and Research in Ayurveda Jamnagar Gujarat-361008
Jamnagar
GUJARAT
361008
India |
| Phone |
7737379173 |
| Fax |
|
| Email |
drpawar29@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nachita |
| Designation |
M.S.Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar,Gujarat |
| Address |
Department of Shalakya Tantra,4th floor,Institute of Teaching and Research in Ayurveda,Jamnagar-361008,Gujarat,India
Jamnagar
GUJARAT
361008
India |
| Phone |
9812280880 |
| Fax |
|
| Email |
nachitay.98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institite of Teaching and Research in Ayurveda, Opp B Divison Police station,Jamnagar,Gujarat-361008,India |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda,Jamnagar,Gujarat-361008 |
| Address |
Department of Shalakya Tantra,4th floor,Institute of Teaching and Research in Ayurveda,Jamnagar,Gujarat-361008,India |
| 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 Nachita |
Institute of Teaching and Research in Ayurveda Hospital,Jamnagar |
OPD No.A-2,Department of Shalakya Tantra,Hospital Building,institute of Teaching and research in Ayurveda, Jamnagar
Jamnagar
GUJARAT |
9812280880
nachitay.98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,Institute of Teaching and Research in Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H102||Other acute conjunctivitis. Ayurveda Condition: ABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: TRIPHALADI CHURNA, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: SUKHAMBU), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: SHIGRUPATRADI EYEDROP, Reference: NA, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 3(drops), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: TRIPHALADI CHURNA, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -SUKHAMBU), Additional Information: - | | 4 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: PUNARNAVADI EYEDROP, Reference: NA, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 3(drops), Frequency: tds, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 15 Days, Reference: NA, Route: NA, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18 to 50 years of age with irrespective of Gender,Occupation,Religion,Socio-economic status.
Patients having minimum two clinical symptoms of Amaja Abhishyanda.
Symptoms developed within less than 5 days. |
|
| ExclusionCriteria |
| Details |
Patients having complication of Corneal involvementlike Marginal cornral ulcer,Dacrocystitis,Trachoma,Keratoconjunctivitis sicca,Vernal keratoconjunctivitis,Giant papillary Conjunctivitis, Atopic keratoconjunctivitis,Ptergyium.
Patient with the complaint of Recurrent allergic conjunctivtis.
Uncontrolled systemic disease condition i.e. Diabetes Mellitus,Hypertension,Hepatomegaly.
Pregnant and lactating mother should be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pacification in the clinical features of Amaja Abhishyanda. |
It will be assessed after 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence of signs and symptoms of Amaja Abhishyanda(Acute infective conjunctivits) |
21st & 30th 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)
|
01/05/2025 |
| 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 Yet Recruiting |
| 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
|
Acharya Sushruta extensively discussed the significance of Netra in his Samhita, detailing 76 eye disorders in the Uttaratantra. Among these, Abhishyanda stands out as a Sarvagata Netraroga, considered a primary cause of various eye ailments and categorized as an Aupasargika Roga. Following the comprehensive exploration of Sarvagata Netraroga, Sushruta Samhita devotes four distinct chapters to the treatment of Abhishyanda. It is noted that while Abhishyanda is treatable in its initial stages (Nava Avastha), neglecting treatment could lead to complications like Adhimantha, Hatadimantha, and Drishtinasha.Yogaratnakara, in its chapter on Netra Rogadhikara Chikitsa, classifies eye diseases based on Netra Ama and Niram Avastha. Although Acharya Sushruta does not specifically mention Nava Abhishyanda under the classification of Netra Roga but almost all the diseases mentioned in the Sushruta are of Amaja Avastha itself. The prodromal symptoms of Netra Roga, characterized by Udirna Vedana (pricking pain), Ragata (ocular erythema), Alpha Shophata (mild chemosis), Netrasrava (ocular discharge), Sangharsha (foreign body sensation), Vishushka Bhava (dryness- feeling), Kandu (Itching), Daha (ocular burning), and Netra Gaurava (ocular heaviness), are indicative of a potential progression to Amaja Abhishyanda. Prevalence rate of Conjunctivtis is 10% to 30% of the general population with a recurrence rate of 41-62% cases has an equal distribution more or less throughout the world without any exception to the developed and developing countries.Approximately 40 to 45 patients of Conjunctivtis reported per month in the OPD of the Shalakya Tantra Department ,ITRA,Jamnagar. Out of those 8 to 10 patients have symptoms of Amaja Abhishyanda .(Acute infective Conjunctivitis).In the contemporary system of medicine on Acute infective Conjunctivitis,antibiotics have some complications with more recurrence rate and as discussed above only few research works have been carried out on Amaja Abhishyanda (Acute infective Conjunctivitis) in Ayurveda.From the clinical manifestation point of view,symptoms of Amaja Abhishyanda can be comapred with the Acute infective Conjunctivitis in the modern science. |