| CTRI Number |
CTRI/2021/04/032764 [Registered on: 12/04/2021] Trial Registered Prospectively |
| Last Modified On: |
23/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [JATAMAANSI TAILA] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
earpooling and head massage in Nidranasha |
|
Scientific Title of Study
|
A Comparative Clinical Evaluaion of Jatamaansi Taila Karnapoorana and Shiroabhyanga in Nidranasha W.S.R.to Insomnia |
| Trial Acronym |
Karnashiro |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepika Dave |
| Designation |
MD Scholar |
| Affiliation |
Government P.G. Ayurveda College and Hospital,Varanasi |
| Address |
P.G. Department of Panchakarma, Government P.G. Ayurveda College and Hospital, Choukaghat, Varanasi, Uttar pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8543079965 |
| Fax |
|
| Email |
deepikadave45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepika Dave |
| Designation |
MD Scholar |
| Affiliation |
Government P.G. Ayurveda College and Hospital,Varanasi |
| Address |
P.G. Department of Panchakarma, Government P.G. Ayurveda College and hospital, Choukaghat, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8543079965 |
| Fax |
|
| Email |
deepikadave45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika Dave |
| Designation |
MD Scholar |
| Affiliation |
Government P.G. Ayurveda College and Hospital,Varanasi |
| Address |
P.G. Department of Panchakarma, Government P.G. Ayurveda College and Hospital, Choukaghat, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8543079965 |
| Fax |
|
| Email |
deepikadave45@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government P.G. Ayurveda college and Hospital, Varanasi, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL VARANASI UTTAR PRADESH |
| Address |
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI, UTTAR PRADESH |
| Type of Sponsor |
Research institution and hospital |
|
|
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 P L Sankhua |
Government P.G. Ayurveda College and Hospital, Varanasi, Uttar Pradesh |
OPD and IPD, Department of Panchakarma, Government P.G. Ayurveda College and Hospital, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH |
7376468851
pls_bls@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC , Government Post Graduate Ayurvedic College and Hospital, Sampurnanand Sanskrit University, Varanasi, U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F99||Mental disorder, not otherwise specified. Ayurveda Condition: NIDRANASH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jatamaansi tail Karnapoorana |
5ML Jatamansi Taila poured in both ear one by one in evening time for 1000 vakmatra, duration 15 days. |
| Comparator Agent |
Jatamaansi Taila Shiroabhyanga |
10ML Jatamaansi Taila is applied over head and massaged for 5 minutes at night for 15 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.difficulty in falling asleep, or maintaining sleep , or poor quality sleep.
2. If the sleep disturbances have occured 3 times a week for at least one month.
3. If the unsatisfactory quality and quantity of sleep either has caused distress or interferes with social and occupational functioning |
|
| ExclusionCriteria |
| Details |
1. Any mental disorders.
2. Patients on medications that interferes with normal quality of sleep.
3. Insomnia due to other causes like that of madatyaya, abhighata, or systemic disease.
4. Patients ayogya of abhyanga.
5. Patients with ruptured eardrum, ear injury, or having any acute or chronic ENT disease or any inflammatory ENT disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sleep quantity. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NO RECURRENCE OF SIGNS AND SYMPTOMS |
15 DAYS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2021 |
| Date of Study Completion (India) |
24/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
comparative clinical study of jatmansi taila karnapoorana and shiroabhyanga in nidranasha: a clinical study
www.wjpps.com
volume 11 issue 4 2022 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
CLINICAL STUDY SETTING:Patient suffering from nidranasha will be selected from OPD and IPD of government PG ayurveda college and hospital, choukaghat, varanasi, 221002. Inclusion Criteria : Patients between age group 20-60 yrs, both gender,having clinical eatures of nidranasha Exclusion criteria : mental disorders, ruptured eardrum, ear injury, patients ayogya of ahyanga Grouping : 60 patients were randomly assigned in two groups Group 1 -5ml of jatamaansi taila was poured in both ear one by one for 1000 vakamatra for 15 days. Group 2 - 20ml of jatmaansi taila is massaged in head for 5 minutes daily, duration 15 days. Follow up will be done on 15th day the treatment and 15 days after completion of treatment. Statistical method of analysis : paired t test was used to know the efficacy of both karnapoorana and shiroabhyanga which came out to be highly significant in both treatment separately. Global PSQI score is the sum of all the seven components of PSQI, when the mean values are compared, the difference between them before treatment and after treatment came .93333 in group A and 1.7333 in group B. It showed highly significant improvement, which indicates Jatamamsi taila karnapoorana and shiroabhyanga helps in producing highly significant improvement in Nidranasha.
For comparison of both groups unpaired t test was used which showed the 30 patients who had shiroabhyanga (PSQI M= 1.7333 SD = .44978) compared to the 30 patients who had karnapoorana (PSQI M = .9333 SD = .44978) demonstrated significantly better peak flow scores, t(104.163) = 3.247 , p-value = .003. overall assesment: Group A: out of 60 patients, 3 patients got marked improvement,18 patients got moderate improvement and 9 patients with mild improvement were observed. Group B: out of 60 patients, 17 patients had marked improvement and 13 patients had moderate improvement.
|