| CTRI Number |
CTRI/2025/01/079308 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Pathadi Taila Nasya and Vyaghri Haritaki Avaleha in Paranasal Sinusitis. |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Pathadi Taila Nasya along with Vyaghri Haritaki Avaleha versus Anu Taila Nasya and Vyaghri Haritaki Avaleha in the management of Nasavivar Shotha (Paranasal Sinusitis): A Randomized Control 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 |
Dr Suraj Sadashiv Patlekar |
| Designation |
PhD Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
| Address |
Dept of Shalakya Tantra, MGACH and Research Centre, Salod(H), Wardha-Nagpur, Maharashtra
DMIHER(DU),Sawangi(Meghe), Wardha 07152-287701-06
Nagpur
MAHARASHTRA
442107
India |
| Phone |
9923852395 |
| Fax |
|
| Email |
surajpatlekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shraddha Jain |
| Designation |
PhD, MBBS, HOD & Professor- Dept of ENT |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
| Address |
JNMC, DMIHER(DU)Salod(H), Wardha-Nagpur
DMIHER(DU),Sawangi(Meghe), Wardha 07152-287701-06
442107
Nagpur
MAHARASHTRA
442005
India |
| Phone |
9881836366 |
| Fax |
|
| Email |
sjain_med@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suraj Sadashiv Patlekar |
| Designation |
PhD Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
| Address |
Dept of Shalakya Tantra, MGACH and Research Centre, Salod(H), Wardha-Nagpur, Maharashtra
DMIHER(DU),Sawangi(Meghe), Wardha 07152-287701-06
Nagpur
MAHARASHTRA
442107
India |
| Phone |
9923852395 |
| Fax |
|
| Email |
surajpatlekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGACH and Research Centre, Salod(H), Wardha, Nagpur, Maharashtra 442001 |
|
|
Primary Sponsor
|
| Name |
Dr Suraj Sadashiv Patlekar |
| Address |
MGACH and Research Centre, Salod(H), Wardha, Nagpur, Maharashtra 442001 |
| Type of Sponsor |
Other [Dr Suraj Sadashiv Patlekar (Self)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Suraj Sadashiv Patlekar |
MGACH and Research Centre, Salod(H), Wardha, Nagpur, Maharashtra 442107 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suraj Sadashiv Patlekar |
MGACH and RC |
OPD and IPD of ShalakyaTantra Department
Wardha
MAHARASHTRA |
9923852395
surajpatlekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M.G.A.C.H. and R.C. INSTITUTIONAL ETHICS COMMITTEE, Salod(H), Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:3||Administration. Ayurveda Condition: NASASVAYATHUH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: ANU TAILA, Reference: CHARAK SAMHITA SUTRASTHANA 5/63-70, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: ANU TAILA NASYA ALONGWITH VYAGHRI HARITAKI AVALEHA 5gms-10gms/day,BID After food with Sukhoshna Jala as Anupana for 60 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PATHADI TAILA, Reference: SHARANGDHARA MADHYAMKHANDA 9/178, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: PATHADI TAILA ALONGWITH VYAGHRI HARITAKI AVALEHA 5gms-10gms/day,BID After food with Sukhoshna Jala as Anupana for 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs & symptoms of Nasavivar Shotha (Paranasal Sinusitis) & fulfilling the criteria for Sinusitis set by the American Academy of Otolaryngology, Head & Neck Surgery (AAO-HNS).
Patients whose medical history along with physical examination, radiographic findings (Opacification/haziness of Sinus with Mucosal Thickenings; Air Fluid Level) suggested paranasal sinusitis i.e Caldwell/Waters View.
|
|
| ExclusionCriteria |
| Details |
- Unwilling patients for trial/giving written consent.
- Patient requiring Surgical/ other Interventions.
- Pregnant ladies/ Lactating mothers.
- Patients having/diagnosed cases of Diabetes, Hypertension, Hepatic Disease, Renal Disorders, Metabolic & GIT disorders, Poor Health Status, Malignancy, Tuberculosis, AIDS or other major Systemic Disorders.
- Hypersensitivity to any of the trial medicines.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the comparative efficacy of Pathadi Taila Nasya alongwith Vyaghri Haritaki and Anu Taila Nasya along with Vyaghri Haritaki Avaleha in the management of Nasavivar Shotha (Paranasal Sinusitis).
|
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Improvement in the clinical features of Nasavivar Shotha in Grading/Scoring.All subjective criteria will be recorded for score in each & every patient before & after treatment.
2) Improvement in the objective parameters with the help of CT SCAN PNS |
60 days |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0"
Months="6"
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
|
RESEARCH HYPOTHESIS
H0: There is no significant difference in the efficacy of Pathadi Taila Nasya & Anu Taila Nasya with Vyaghri Haritaki Avaleha in the management of Nasavivar Shotha (Paranasal Sinusitis).
H1: There is statistically significant difference in the efficacy of Pathadi Taila Nasya & Anu Taila Nasya along with Vyaghri Haritaki Avaleha in the management of Nasavivar Shotha (Paranasal Sinusitis). |