| CTRI Number |
CTRI/2025/03/082558 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the effect of Vyaghri Haritaki and Vyaghri Taila Nasya in the management of Dushta Pratishyaya w.s.r. to Chronic Sinusitis |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Vyaghri Haritaki orally and Vyaghri Taila Nasya in the management of Dushta Pratishyaya w.s.r. to Chronic Sinusitis |
| 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 Vijayant Bhardwaj |
| 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 |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vijayant Bhardwaj |
| Designation |
Professor |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P. 176115 |
| Address |
Room no. 210,PG Department of Shalakya Tantra, Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
H.P. 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayant Bhardwaj |
| 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 |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola,
Kangra, H.P. |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital,
Paprola, Distt. Kangra, H.P. 176115, India |
| Type of Sponsor |
Government 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 Vijayant Bhardwaj |
Rajiv Gandhi Govt Ayurvedic college and Hospital , Paprola |
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 |
9418017568
bhardwajvijayant@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:J988||Other specified respiratory disorders. Ayurveda Condition: DUSHTAPRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् Pradhan Karma | (Procedure Reference: Bhaishajya Ratnavali, Procedure details: 8 drops to be instilled each nostril in day time for seven days with
3 days interval, in 3 attempts.
Route of administration: Nasal
)
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vyaghari Haritaki, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Dugdha), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria based on signs and symptoms of Dushta Pratishyaya (Chronic Sinusitis) in Ayurveda classics and modern science.
Patient willing to participate.
Patient of either gender in the age group above 12 years.
|
|
| ExclusionCriteria |
| Details |
Patient not willing for the trial.
Patients requires surgical treatment e.g. cases of nasal polyp.
Patients with history of multiple episodes of epistaxis.
Patients below age of 12 years.
Patient suffering from diseases like Diabetes mellitus, Carcinoma, Tuberculosis.
Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Chronic sinusitis with in patient |
Relief in sign and symptoms of Chronic sinusitis with in patient with in 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Vyaghri Haritaki orally and Vyaghri Taila Nasya in the management of Dushta Pratishyaya w.s.r. to Chronic Sinusitis” |
30 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)
|
21/04/2025 |
| 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 trial as soon as possible. patients will be selected from OPD/IPD of RGGPG Ayurvedic college and hospital Paprola HP. 3 groups of 30 patient will be registered and assessed to evaluate the effect of Vyaghri haritaki orally and Vyaghri taila nasya in managment o Dushta Pratishaya w.s.r to Chronic Sinusitis. |