| CTRI Number |
CTRI/2021/06/034121 [Registered on: 09/06/2021] Trial Registered Prospectively |
| Last Modified On: |
08/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Procedure named nasya in two different methods with already proven medicines] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two methods of nasya in patients with chronic sinusitis |
|
Scientific Title of Study
|
Effect of EkÄhÄntara (alternate day) nasya with Tuḷasi patṟa svarasa (Ocimum sanctum Linn.) and Aṇutaila against EkÄhÄntara nasya with Tuḷasi patṟa svarasa in Chronic
sinusitis- A comparative clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Remya T M |
| Designation |
PG SCHOLAR |
| Affiliation |
VAIDYARATNAM PS VARIER AYURVEDA COLLEGE KOTTAKKAL |
| Address |
DEPARTMENT OF PANCHAKARMA
VAIDYARATNAM PS VARIER AYURVEDA COLLEGE
KOTTAKKAL
nil
Malappuram
KERALA
676501
India |
| Phone |
9447378935 |
| Fax |
0 |
| Email |
drremyatm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Remya T M |
| Designation |
PG SCHOLAR |
| Affiliation |
VAIDYARATNAM PS VARIER AYURVEDA COLLEGE KOTTAKKAL |
| Address |
DEPARTMENT OF PANCHAKARMA
VAIDYARATNAM PS VARIER AYURVEDA COLLEGE
KOTTAKKAL
nil
Malappuram
KERALA
676501
India |
| Phone |
9447378935 |
| Fax |
0 |
| Email |
drremyatm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BINITHA A |
| Designation |
PROFESSOR |
| Affiliation |
VAIDYARATNAM PS VARIER AYURVEDA COLLEGE KOTTAKKAL |
| Address |
DEPARTMENT OF PANCHAKARMA
VAIDYARATNAM PS VARIER AYURVEDA COLLEGE
KOTTAKKAL
nil
Malappuram
KERALA
676501
India |
| Phone |
9895201635 |
| Fax |
0 |
| Email |
drbinithaunni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam P S Varier Ayurveda College Kottakkal |
|
|
Primary Sponsor
|
| Name |
VPSV AYURVEDA COLLEGE KOTTAKKAL |
| Address |
DEPARTMENT OF PANCHAKARMA
VPSV AYURVEDA COLLEGE
KOTTAKKAL, EDARIKODE P O |
| Type of Sponsor |
Other [AIDED AYURVEDA MEDICAL COLLEGE] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| BINITHA A |
PROFESSOR
DEPARTMENT OF PANCHAKARMA
VPSV AYURVEDA COLLEGE
KOTTAKKAL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| REMYA T M |
VPSV AYURVEDA COLLEGE HOSPITAL |
DEPARTMENT OF PANCHAKARMA
VPSV AYURVEDA COLLEGE
KOTTAKKAL
Malappuram
KERALA |
9447378935
drremyatm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF VAIDYARATNAM PS VARIER AYURVEDA COLLEGE, KOTTAKKAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, (2) ICD-10 Condition:J329||Chronic sinusitis, unspecified. Ayurveda Condition: DUSHTAPRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EKAHANTARA ( ALTERNATE DAY)NASYA WITH TULASIPATRA (Ocimum Sanctum Linn.)SVARASA |
NASYA (NASAL ADMINISTRATION ) WITH 2ML TULASIPATRA SVARASA IN ALTERNATE DAYS WITH A GAP DAY IN BETWEEN, TOTAL 3 DAYS TULASI PATRA SVARASA NASYA. 2ML IS GIVEN AS DIVIDED DOSE ie. 2 INSTILLATIONS OF 1ML. DURING FOLLOW UP PERIOD PATHYAKSHA DHATRYADI KASHAYA WILL BE GIVEN ORALLY FOR 15 DAYS |
| Intervention |
EkÄhÄntara (alternate day) nasya with Tuḷasi patṟa svarasa (Ocimum sanctum Linn.) and Aṇutaila |
NASYA (NASAL ADMINISTRATION) WITH 2ML TULASIPATRA SVARASA AND 2ML ANUTAILA ON ALTERNATE DAYS FOR 7 DAYS( first day nasya with anutaila, second day nasya with tulasipatra svarasa like that for 7 days; total 4 anutaila nasya and 3 tulasipatra svarasa nasya
2ml of medicine is administered as divided doses, ie. 2 instillations of 1ml.
during follow up period pathyaksha dhatryadi kashaya will be given orally for 15 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Eligible for nasya
2.Participants with informed consent
|
|
| ExclusionCriteria |
| Details |
1.Blood stained nasal discharge
2.Nasal polyp
3. History of polypectomy and sinus surgery within 3 months
4. Other known systemic diseases
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Collected data will be assessed using Rhinosinusitis Disability Index, Visual Analogue Scale and Scale for scoring of symptoms (before trial, after trial and after follow up) for 22 days and Event evaluation scale and Samyak nasya lakṣaṇa (on each day of nasya) for 7 days and outcome will be presented in the form of dissertation. |
22 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Event evaluation scale and Samyak nasya lakṣaṇa (on each day of nasya) for 7 days |
7 days |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
30/06/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Would like to publish in peer reviewed journals |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised, parallel group trial comparing the effectiveness of alternate day nasya with tulasipatra svarasa and anutaila with alternate day nasya with anutaila in chronic sinusitis for 7 days in a total 42 patients in India. The primary outcome of this study is to assess Rhinisinusitis disability index, Visual analogue scale, Scale of scoring of symptoms for 22 days. Assessment of event evaluation scale and samyak nasya lakshana for 7 days and outcome will be published in the form of dissertation. |