| CTRI Number |
CTRI/2023/05/052768 [Registered on: 17/05/2023] Trial Registered Prospectively |
| Last Modified On: |
16/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate effect of mustard oil nasal drops on quality of sleep |
|
Scientific Title of Study
|
Evaluation of effect of katu Taila pratimarsha Nasya w.s.r.to quality of sleep |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Umesh Shukla |
| Designation |
Head of Department of Swasthavritta department |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
Room no 410 Swasthavritta Department Anatomy block RGGPG Ayurvedic College and hospital paproladistrict kangra
Himachal pradesh
176115
India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018242861 |
| Fax |
|
| Email |
drumeshshukla1969@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Shukla |
| Designation |
Head of Department of Swasthavritta department |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
Room no 410 Swasthavritta Department Anatomy block RGGPG Ayurvedic College and hospital paproladistrict kangra
Himachal pradesh
176115
India
HIMACHAL PRADESH
176115
India |
| Phone |
7018242861 |
| Fax |
|
| Email |
drumeshshukla1969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh Shukla |
| Designation |
Head of Department of Swasthavritta department |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
Room no 410 Swasthavritta Department Anatomy block RGGPG Ayurvedic College and hospital paproladistrict kangra
Himachal pradesh
176115
India
HIMACHAL PRADESH
176115
India |
| Phone |
7018242861 |
| Fax |
|
| Email |
drumeshshukla1969@gmail.com |
|
|
Source of Monetary or Material Support
|
| RGGPG Ayurvedic College and Hospital Paprola District kangra |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College and Hospital Paprola District kangra |
| Address |
Department of Swasthavritta RGGPG Ayurvedic College and Hospital Paprola |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Umesh Shukla |
Room no 410 Swasthavritta department Anatomy block RGGPG Ayurvedic College and Hospital Paprola District kangra Himachal Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shilpa pal |
RGGPG Ayurvedic College and Hospital Paprola District kangra Himachal Pradesh |
Room no 410 Department of Swasthavritta Anatomy block RGGPG Ayurvedic College and Hospital Paprola District kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH |
8219359594
palshilpa68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(human) RGGPG Ayurvedic College and Hospital Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Nasya | (Procedure Reference: Bhav prakash 5/47-48, Procedure details: 2 drops in each nostril should be administered to the individual at evening time(before sunset))
(1) Medicine Name: Katu taila, Reference: Bhav prakash 5/47-48, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy volunteers Willing for trial
Written consent of the volunteers will be obtained before inclusion in the trial |
|
| ExclusionCriteria |
| Details |
volunteers having any associated chronic ailments
Pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the quality of sleep |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in smooth functioning of sense organs,wrinkles,greying of hair,chloasma |
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2023 |
| 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="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this trial Katu taila pratimarsha nasya is given to the individuals and purpose of this trial is to improve in quality of sleep, greying of hair, wrinkles,chloasma and lightness in upper region.In this procedure there is indication of not to engulf the taila rather spit it out when it reached the throat. |