| CTRI Number |
CTRI/2022/02/040386 [Registered on: 17/02/2022] Trial Registered Prospectively |
| Last Modified On: |
16/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study to see the effectiveness of oil retention in head and oil retention in forehead with tungadrumadi taila in sleeplessness
|
|
Scientific Title of Study
|
A randomised comparative clinical study to evaluate the effectiveness of shirobasti and lalata basti with tungadrumadi taila in nidranasha (Primary Insomnia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhanya V Nair |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India
Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
8848467745 |
| Fax |
|
| Email |
dhanyavnair63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanya V Nair |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India
Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
8848467745 |
| Fax |
|
| Email |
dhanyavnair63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muralidhar P Pujar |
| Designation |
Professor Department of Panchakarma |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India
Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9448033718 |
| Fax |
|
| Email |
drmuralidharppujar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India College Phone:08172256460 Email: sdmcah@gmail.com |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India |
| Type of Sponsor |
Private 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 Dhanya V Nair |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Department of Panchakarma,OPD 5, SDM College of Ayurveda and Hospital Hassan 573201.
Hassan
KARNATAKA |
8848467745
dhanyavnair63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F510||Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | SirobastiH, शिरोबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Ashtanaga Hridaya Sutra sthana. Gandooshavidhi Adhyaya, Procedure details: 53 minutes each day for 7 consecutive days)
(1) Medicine Name: Tungadrumadi taila, Reference: Sahasrayoga taila prakarana, Route: Topical, Dosage Form: Taila, Dose: 500(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | Lalata Basti | (Procedure Reference: Ashtanga Hridaya Sutra sthana. Gandooshvidhi adhyaya, Procedure details: 53 mins each day for 7 consecutive days)
(1) Medicine Name: Tungadrumadi taila, Reference: Sahasrayoga taila prakarana, Route: Topical, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Difficulty in falling asleep,maintain sleep or nonrefreshing sleep
2)Sleep disturbance occur atleast three times per week for atleast one month
3)Sleep disturbance results in marked personal distress or interferance with personal functioning in daily living
|
|
| ExclusionCriteria |
| Details |
1)Known cases of alcoholism
2)Known cases of psychiatric illness
3)Previously diagnosed medical or surgical disorders
4)Patients suffering from ajeerna |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Samyak shirobasti lakshanas will be observed
1)Asya srava
2)Nasikotklesha
3)Karnasrava |
1-2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The effect of therapy will be assessed on the basis of relief of following signs and symptoms of nidranasha which will be assigned suitable scores (Insomnia Severity Index Scale)
1)Jrimbha
2)Angamarda
3)Thandra
4)Akshigourava
5)Shirogourava |
Measures will be assessed by giving proper gradings before treatment after lalata basti after 15 days in subjects of Group A In Group B measures will be assessed before treatment after shirobasti after 15 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)
|
01/03/2022 |
| 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="3" |
|
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 study is an open label ,double arm randomised prospective clinical trial to evaluate the effectiveness of shirobasti and lalata basti with tungadrumadi taila in nidranasha(Primary Insomnia)that will be conducted in India.Primary outcome measures will be asya srava,nasikotklesha,karnasrava and secondary outcome measures will be assessed on the basis of relief in signs and symptoms of nidranasha which will be assigned suitable scores(Insomnia severity index scale)Time points will be before treatment after lalata basti after 15 days in subjects of Group A In Group B measures will be assessed before treatment after shirobasti after 15 days |