| CTRI Number |
CTRI/2020/11/029277 [Registered on: 20/11/2020] Trial Registered Prospectively |
| Last Modified On: |
12/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of matrabasti in insomnia |
|
Scientific Title of Study
|
A Randomized,Controlled, Clinical Study Of Efficacy Of Matrabasti In Anidra With Special Refrence To Primary Insomnia. |
| Trial Acronym |
RAMA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amruta Arjun Chavare |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved Hospital Nanded |
| Address |
Government Ayurved College
Vazirabad, Nanded ,Maharashtra
Government Ayurved College
Vazirabad,Kayachikitsa department,Nanded, Maharashtra
Nanded
MAHARASHTRA
431601
India |
| Phone |
9021026788 |
| Fax |
|
| Email |
chavareamruta85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMRUTA ARJUN CHAVARE |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVED HOSPITAL NANDED |
| Address |
GOVERNMENT AYURVED COLLEGE
VAZIRABAD, NANDED ,MAHARASHTRA
GOVERNMENT AYURVED COLLEGE
VAZIRABAD,NANDED, MAHARASHTRA
MAHARASHTRA
431601
India |
| Phone |
9021026788 |
| Fax |
|
| Email |
chavareamruta85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amruta Arjun Chavare |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved Hospital Nanded |
| Address |
Government Ayurved College
Vazirabad, Nanded,Maharashtra
Government Ayurved College
Vazirabad,Nanded, Maharashtra
Nanded
MAHARASHTRA
431601
India |
| Phone |
9021026788 |
| Fax |
|
| Email |
chavareamruta85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College,Kayachikitsa Department,Nanded |
|
|
Primary Sponsor
|
| Name |
Amruta Arjun Chavare |
| Address |
Government ayurved college vazirabad nanded 431601 Maharashtra India |
| Type of Sponsor |
Other [(Own funded)] |
|
|
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 |
| DRSVSURYAVANSHI |
Government Ayurved College Nanded Kayachikitsa OPD |
Government Ayurved College Kayachikitsa
Vazirabad,Nanded,Maharashtra
Nanded
MAHARASHTRA |
9284025059
drsharmili24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Insomnia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Matrabasti with Tila Taila for 7 days in patients having primary insomnia |
Matrabasti with 60 ml Tila Taila for 7 days in ano rectal route in patients having primary insomnia |
| Comparator Agent |
Shirodhara with Tila Taila for 7 days once in a day in patients having primary insomnia |
Shirodhara with Tila Taila for 7 days once in a day in patients having primary insomnia |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient already diagnosed for primary insomnia by APA2000 diagnostic criteria
• Patient who are suffering from the signs and symptoms of anidra and willing for treatment.
• Subjects from either sex will be selected.
• Patients between 40-60 years age group.
• Subjects will be selected irrespective of socioeconomic conditions
• Patient complaining of reduction in sleep time, difficulty in initiation of sleep, unsatisfactory sleep and disturbed sleep either any of these or all of these.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from anidra due to other conditions like madatyaya and abhighata
Patients suffering from anidra associated with other systemic and metabolic disorders like renal diseases cardiac diseases / endocrinal diseases / tuberculosis.
• Insomnia due to addiction
• Insomnia due to severe psychic disorder
• Lactating women
• Pregnant women
• Uncontrolled Diabetes Mellitus and Hypertension.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Induction of normal sleep in patients having primary insomnia and reduction of score of Athense Insomnia Scale and Insomnia Severity Index scale |
Assesment on 0,3,5,7 th day and follow up on 15 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Induction of normal sleep in patients having primary insomnia |
7 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 2 |
|
Date of First Enrollment (India)
|
15/12/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The study will be submitted in the form of dissertation as a part of Postgraduate course to Maharashtra University Of Health Sciences |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized,controlled,clinical study of effect of matrabasi with tila taila in patients having primary insomnia for 7 days and follow up of patients will be taken on 15 th day.The primary outcome is reduction of Athens Insomnia Scale score and Insomnia Severity Index Score. |