| CTRI Number |
CTRI/2020/11/029425 [Registered on: 27/11/2020] Trial Registered Prospectively |
| Last Modified On: |
26/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
herbal medicine and mantra chanting for lack of sleep |
|
Scientific Title of Study
|
A Clinical Study of Pancharvya Ghrita and Mantra Ucharana in Mnagment of Anindra w.s.r to 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 Babita Kumari |
| Designation |
M.D. Scholar |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
P. G. Department of Swasthavirtta, university college of Ayurved, DSRRAU, karwar, Nagaur road, Jodhpur, Rajasthan
P. G. Department of Swasthavirtta, university college of Ayurved, DSRRAU, karwar, Nagaur road, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7891290176 |
| Fax |
|
| Email |
drbabita153@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Kumar Mishra |
| Designation |
Associate Professor & HOD |
| Affiliation |
DSSRRAU, Jodhpur |
| Address |
P. G. Department of Swasthavirtta, university college of Ayurved, DSRRAU, karwar, Nagaur road, Jodhpur, Rajasthan
P. G. Department of Swasthavirtta, university college of Ayurved, DSRRAU, karwar, Nagaur road, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9001009793 |
| Fax |
|
| Email |
drpramodmishra4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Babita Kumari |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
P. G. Department of Swasthavirtta, university college of Ayurved, DSRRAU, karwar, Nagaur road, Jodhpur, Rajasthan
P. G. Department of Swasthavirtta, university college of Ayurved, DSRRAU, karwar, Nagaur road, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7891290176 |
| Fax |
|
| Email |
drbabita153@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Ayurveda Karwar jodhpur Pin 342304 |
|
|
Primary Sponsor
|
| Name |
DrSavepalli Radhakrishnan Rajasthan Ayurved University jodhpur |
| Address |
University College of Ayurveda Jodhpur |
| Type of Sponsor |
Government 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 Babita Kumari |
University College of Ayurved |
Dr sarvepalli Radhakrishanan Rajasthan Ayurveda university Jodhpur
Jodhpur
RAJASTHAN |
7891290176
drbabita153@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Panchagva Ghrita |
25 ml of ghrita twice a day before meal with luke warm water for 45 days |
| Comparator Agent |
Ratrisukta |
Chanting of Ratri sukta once in a day before going to bed for 45 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex between the age group of 20 to 60 yrs.
2. Patients with symptoms of insomnia.
3. Insomnia with the history of minimum 1 month.
|
|
| ExclusionCriteria |
| Details |
1. Volunteers of both sexes who were not following the inclusion criteria for age were excluded from the study.
2. Volunteers or patients who were suffering from major psychiatric illness, chronic disease and acute condition were excluded from the study.
3.Patients suffering from other symptomatic illness and on other medications.
4.Alcoholic drug user and drug dependent were also excluded from the study to achieve better result.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective and objective parameter |
1 month and 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the efficacy of treatment |
1 month and 15 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
07/12/2020 |
| 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="15" |
|
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 a random parallel group trial of patient suffering from primary insomnia will be given Panchgavya ghrita before meal with lukewarm water for 45 days and patient will be adviced for mantra chanting before going to bed this trial is of 1 month and 45 days. |