| CTRI Number |
CTRI/2025/04/085608 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO SEE THE EFFECT OF DHATRIFAL NIRYAS PARISHEK ON VATAJ ABHISHYAND W.S.R TO ALLERGIC CONJUNCTIVITIS |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF DHATRIPHAL (EMBELICA OFFICINALE)NIRYAS PARISHEK IN THE MANAGEMENT OF VATAJ ABHISHYAND W.S.R 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 |
DrTrushal Anil yadav |
| Designation |
PG Resident |
| Affiliation |
SST Ayurvedic college |
| Address |
Sst Ayurved Mahavidyalaya,Shalakyatantra OPD,Room No 3,In Front Of Prasad Hotel,Sangamner,Ahmadnagar
Sst Ayurved Mahavidyalaya,Shalakyatantra OPD,Room No 3,In Front Of Prasad Hotel,Sangamner,Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8329989377 |
| Fax |
nil |
| Email |
drtrushalyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTrushal Anil yadav |
| Designation |
PG Resident |
| Affiliation |
SST Ayurvedic college |
| Address |
Sst Ayurved Mahavidyalaya,Shalakyatantra OPD,Room No 3,In Front Of Prasad Hotel,Sangamner,Ahmadnagar
Sst Ayurved Mahavidyalaya,Shalakyatantra OPD,Room No 3,In Front Of Prasad Hotel,Sangamner,Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8329989377 |
| Fax |
nil |
| Email |
drtrushalyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrTrushal Anil yadav |
| Designation |
PG Resident |
| Affiliation |
SST Ayurvedic college |
| Address |
Sst Ayurved Mahavidyalaya,Shalakyatantra OPD,Room No 3,In Front Of Prasad Hotel,Sangamner,Ahmadnagar
Sst Ayurved Mahavidyalaya,Shalakyatantra OPD,Room No 3,In Front Of Prasad Hotel,Sangamner,Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8329989377 |
| Fax |
nil |
| Email |
drtrushalyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sst Ayurved Mahavidyalaya,Shalakyatantra OPD,Room No 3,In Front Of Prasad Hotel,Sangamner,Ahmadnagar |
|
|
Primary Sponsor
|
| Name |
SSTAyurvedic mahavidyalaya sangamner |
| Address |
Sst Ayurved Mahavidyalaya,Shalakyatantra OPD,Room No 3,In Front Of Prasad Hotel,Sangamner,Ahmadnagar |
| 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 Trushal Anil Yadav |
SST Ayurved Collage |
Shalakyatantra OPD Ground FloorShalakyatantra department SST Ayurvedic college opp to prasad hotel sangamner nashik highway Ghulewadi
Ahmadnagar
MAHARASHTRA |
8329989377
-
drtrushalyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 | - | Abhishek | (Procedure Reference: The Ayurvedic Pharmacopoeia of India, Part–I, Volume - IX (Extracts), Appendix 5. , Procedure details: patient is made to lie down in supine position and made to close his/her eyelids. Dhatriphal Niryasa parisheka will be used after brought down to room temperature and this medicated liquid will be poured from a height of 4 anguli ,which is equal to 7.8 cm ac-cording to API guidelines23 ,on the affected eye for a span of 400 matra (600ml) which is approximate 10 min according to API guidelines23for 5 days twice a daily.Liquid used in the Netr Parishek Vidhi is 600 ml according to pilot study.)
(1) Medicine Name: Dhatrifal Niryas, Reference: Shri Ambikadutta shastri, Bhaishajya Ratnawali, Adhyaya 64th, shlok no. 6, Chaukhambha prakashan, Varanasi, Re-print, 2018, 690., Route: Topical, Dosage Form: Swaras/ Juice, Dose: 600(ml), Frequency: bd, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | Abhishek | (Procedure Reference: The Ayurvedic Pharmacopoeia of India, Part–I, Volume - IX (Extracts),Appendix 5, Procedure details: patient is made to lie down in supine position & made to close his/her eyelids. Dhatriphal Niryasa parisheka will be used after brought down to room temperature & this medicated liquid will be poured from a height of 4 anguli ,which is equal to 7.8 cm ac-cording to API guidelines23 ,on the affected eye for a span of 400 matra (600ml) which is approximate 10 min according to API guidelines23for 5 days twice a daily.Liquid used in the Netr Parishek Vidhi is 600 ml according to pilot study.)
(1) Medicine Name: Mahatriphala Ghrit, Reference: Shri Ambikadhaishajya Ratnawautta shastri, Bli, Adhyaya 64th, shlok no. 249-256, Chaukhambha prakashan, Varanasi, Reprint, 2018, 1013., Route: Topical, Dosage Form: Ghrita, Dose: 600(ml), Frequency: bd, Duration: 7 Days |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group of 18 to 60 years will be included in the study.
2.Patient suffering from symptoms of Vataj Abhishyanda i.e
1. Nistoda (Pricking sensation in eyes)
2. Vishushkabhava (Feeling of Dryness in eyes)
3. Shishirashruta (Lacrimation of eyes )
4. Kandu (Itching of eyes)
5. Sangharsh (foreign body sensation of eyes)
6. Ragata (Readness of eyes)
7. Daha (Burning sensation of eyes)
|
|
| ExclusionCriteria |
| Details |
1.K/C/O Patient with any other ocular pathology like Bacterial conjunctivitis, corneal opacity, corneal ulcer, Malignancy, Im-munosuppressive disorder.
2.K/C/O Patient with complicated dacryocystitis.
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce Sign And Symptoms Of Vataj Abhishyanda w.s.r to Allergic Congunctivitis |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence of Vataj Abhishyanda w.s.r to Allergic Conjunctivitis |
5 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
05/05/2025 |
| 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
|
As we see the number of patients suffer with conjunctivits are mainly because of allegens they are in get contact with . So to know the efficacy of Dhatrifal Niryas Parishek in Vataj Abhishyandya w.s.r Allergic conjunctivitis in the age group 18 to 60 yrs of male and female on OPD basis. |