| CTRI Number |
CTRI/2022/06/043219 [Registered on: 13/06/2022] Trial Registered Prospectively |
| Last Modified On: |
13/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare effect of vacha pippali nasya and yashtimadhu madhu nasya in suryavarta( frontal sinusitis) |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of yashtimadhu madhu avapeeda nasya with vacha pippali avapeeda nasya in suryavarta( frontal sinusitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aruna C Sekhar |
| Designation |
PG scholar, shalakyatantra |
| Affiliation |
Alvas ayurveda medical college affiliated with RGUHS |
| Address |
Department of PG studies in shalakya tantra, Alvas ayurveda medical college and hospital,Moodbidri, DK district, Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8281324310 |
| Fax |
|
| Email |
dr.arunagauthaman90@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apeksha D Rao |
| Designation |
Associate professor and H.O.D |
| Affiliation |
Alvas ayurveda medical college, affiliated with RGUHS |
| Address |
Department of PG studies in shalakya tantra, Alvas ayurveda medical college and hospital, Moodbidri.
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7411360991 |
| Fax |
|
| Email |
drapekshadrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apeksha D Rao |
| Designation |
Associate professor and H.O.D |
| Affiliation |
Alvas ayurveda medical college affiliated with RGUHS |
| Address |
Department of PG studies in shalakya tantra, Alvas ayurveda medical college and hospital, Moodbidri.
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7411360991 |
| Fax |
|
| Email |
drapekshadrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas ayurveda medical college and hospital, Moodbidri, Karnataka |
|
|
Primary Sponsor
|
| Name |
Chandrasekharan P |
| Address |
Parakkal house,
Palunda,
Chungathara post,
Malappuram district,
Kerala. |
| Type of Sponsor |
Other [Father] |
|
|
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 |
| Aruna C Sekhar |
Alvas ayurveda medical college and hospital |
Alvas ayurveda medical college and hospital,
Vidyagiri,
Moodbidri.
Dakshina Kannada
KARNATAKA |
8281324310
dr.arunagauthaman90@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee , Alvas ayurveda medical college. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J011||Acute frontal sinusitis. Ayurveda Condition: SURYAVARTAH, (2) ICD-10 Condition:J321||Chronic frontal sinusitis. Ayurveda Condition: SURYAVARTAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | avapIDanam, अवपीडनमॠ| (Procedure Reference: Susrutha Samhita Chikitsa Sthana, Procedure details: once a day)
(1) Medicine Name: yashtimadhu, madhu, Reference: Susruta Samhita, uttaratantra, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | avapIDanam, अवपीडनमॠ| (Procedure Reference: SUSRUTA SAMHITA CHIKITSA STHANA, Procedure details: ONCE A DAY)
(1) Medicine Name: VACHA, PIPPALI, Reference: SUSRUTHA SAMHITA, UTTARA TANTRA, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 7 Days |
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient within the age group of 16 to 60 years who will give their written consent
2. pt who will agree to follow protocol of study
3.subjects with symptoms of:
a)shirashoola dinavruddha
b) lalataruk
c)akshiruk
d)shankaruk
e)spandanavat vedana
f)tenderness over sinus area |
|
| ExclusionCriteria |
| Details |
1)Subjects with complications of sinusitis.
2)Pregnant and lactating women.
3)Headaches with involvement of other intracranial pathology.
4)Subjects contraindicated for nasya.
5)Patients with other systemic illness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of treatment will be assessed based on detailed case proforma adopting methods of subjective parameters such as site, intensity and nature of pain. And also according to objective criteria like tenderness over sinus area and ESR. Pre and post interventional assessment will be done |
The effect of treatment will be assessed before treatment( day 0), after treatment( day 7) and on day 14, 21 and 52 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/06/2022 |
| 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="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is randomized control clinical study to evaluate the efficacy of yashtimadhu madhu avapeeda nasya with vacha pippali avapeeda nasya in suryavarta for 7 days in 40 patients in OPD and IPD of PG studies in shalakya tantra of Alvas ayurveda medical college and hospital, Vidyagiri, Moodbidri, DK district, Karnataka. Assessment will be done based on detailed case proforma adopting standard scoring methods of subjective and objective parameters. Pre and post assessment will be done , clinical symptoms will be graded and scores will be given accordingly. |