CTRI Number |
CTRI/2022/03/040953 [Registered on: 09/03/2022] Trial Registered Prospectively |
Last Modified On: |
08/03/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Ayurvedic medicine to get sleep |
Scientific Title of Study
|
Randomized controlled comparative clinical study to evaluate the efficacy of Ashwagandha Vati With Jatamanasi Vati in the management of Nidranasha with special reference to 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 Girish Kale |
Designation |
PG Scholar |
Affiliation |
DY Patil School of Ayurveda |
Address |
DY Patil School of Ayurveda, 3rd floor, Dept of Kayachikitsa, block no. 10, DY Patil Vidyanagar,, Sec 7 , Nerul - 400706 DY Patil School of Ayurveda, 3rd floor, Dept of Kayachikitsa, block no. 10, DY Patil Vidyanagar,, Sec 7 , Nerul - 400706 Thane MAHARASHTRA 410210 India |
Phone |
9404477796 |
Fax |
|
Email |
girishkale000.gk@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ashish Mhatre |
Designation |
Associate Professor |
Affiliation |
DY Patil School of Ayurveda |
Address |
DY Patil School of Ayurveda, DY Patil Vidyanagar, Sec 7 , Nerul
Thane MAHARASHTRA 400706 India |
Phone |
9819639895 |
Fax |
|
Email |
ashishmhatre2010@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ashish Mhatre |
Designation |
Associate Professor |
Affiliation |
DY Patil School of Ayurveda |
Address |
DY Patil School of Ayurveda, DY Patil Vidyanagar, Sec 7 , Nerul
Thane MAHARASHTRA 400706 India |
Phone |
9819639895 |
Fax |
|
Email |
ashishmhatre2010@gmail.com |
|
Source of Monetary or Material Support
|
DY Patil School of Ayurveda and Hospital, DY Patil Vidyanagar, Sec 7 , Nerul - 400706 |
|
Primary Sponsor
|
Name |
Dr Girish Kale |
Address |
A 104, Shree Ganesh Complex, Sec-3, Kharghar, Navi Mumbai 410210 |
Type of Sponsor |
Other [Self] |
|
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 Girish Kale |
DY Patil School of Ayurveda |
3rd floor, Dept of Kayachikitsa, block no. 10, DY Patil Vidyanagar,, Sec 7 , Nerul - 400706 Thane MAHARASHTRA |
9404477796
girishkale000.gk@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: अनिदà¥à¤°à¤¾, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Vati, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: hs, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: - | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatamanasi Vati, Reference: Nighantu Ratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: hs, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Patients between age group 18 -70 years.
2. Patients complaining of reduction in sleep time, difficulty in initiation of sleep, wakefulness during normal sleep
3. Either any of these or all of these for the duration of 1 months or more.
Patients already diagnosed for Primary insomnia.
4. Patient lying in between the range of 8-21 score as per the PSQI scale.
|
|
ExclusionCriteria |
Details |
1. Patient below 18 years and above 70 years.
2. Pregnancy & Lactation.
3. K/C/O any systemic Disorder
4. Patients with major psychiatric illness like schizophrenia, depressive psychosis, etc.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
improvement in PITTSBURGH SLEEP QUALITY INDEX (PSQI) and Jrumbha, Angamarda, Tandra, Shirogaurav
|
Day 1, Day 15, Day 30 |
|
Secondary Outcome
|
Outcome |
TimePoints |
nil |
nil |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
22/03/2022 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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
|
TITLE OF DISSERTATION
“RANDOMIZED CONTROLLED COMPARATIVE
CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASHWAGANDHA VATI WITH
JATAMANASI VATI IN THE MANAGEMENT OF
NIDRANASHA W.R.T. INSOMNIA†AIM AND
OBJECTIVES:
Aim:
Clinical
Study To Evaluate The Efficacy Of Ashwagandha Vati With Jatamanasi Vati In The
Management Of Nidranash w.r.t. Insomnia.
Objectives:
•
To study the
aetiopathogenesis of Nidranasha and correlate it with Ayurveda & Modern
science.
•
To evaluate
the efficacy of Ashwagandha Vati in the management of Nidranasha w.r.t Insomnia.
•
To evaluate
the efficacy of Jatamanasi Vati in the management of Nidranasha w.r.t Insomnia.
•
To compare
the efficacy of Ashwagandha Vati with
Jatamanasi Vati In the Management of Nidranasha w.r.t Insomnia. RESEARCH
QUESTIONS: - Primary
Research Question: - Is Ashwagandha Vati
is effective in the management of Nidranash w.r.t Insomnia? Secondary
Research Question: - Is
the effect of Ashwagandha Vati is significant than Jatamanasi Vati in the
management of Nidranasha w.r.t Insomnia? HYPOTHESIS:
H0 : There
will be no significant effect of Ashwagandha Vati than Jatamanasi Vati in
management of Nidranasha. H1 : There will be significant effect of Ashwagandha Vati than Jatamanasi
Vati in management of Nidranasha. DIAGNOSTIC
CRITERIA:-
1.Difficulty falling asleep, staying asleep or
nonrestorative sleep.
2.Difficulty is present despite adequate opportunity
and circumstance to sleep. 3.Impairment in sleep is associated with daytime impairment or distress. 4.Sleep difficulty occurs at least 3 times per week and has been a problem for
at least 1 month.
METHOD OF COLLECTION OF DATA: -
•
A proforma will be prepared
with details of History, physical examination, pathological investigations.
•
The general condition of the
patient, severity of symptoms before starting the treatment will be recorded
properly. The presenting symptoms will be observed on 0th day, 15th Day, 30th
Day.
SOP OF PREPARATION OF ASHWAGANDHA VATI:-
Raw material for Ashwagandha
will be purchased from authentic pharmaceutical company. The authentication of
drug will be performed from Department of Dravyaguna school of Ayurveda, Nerul
Navi Mumbai. The vati will be formed in the terms of tablets through authentic
GMP certified company and the standardization of raw drugs and tablet formed
will be done from certified company.
The authentic raw
Ashwagandha will be taken followed by Pulverisation to make it into powder form.
Starch, gum acacia will be added as Binder to make granules with binder.
Further then the mixture form will allow to dry in a tray dryer. Eventually equal
size of granules will be prepare by granulator & tablet will be made by
tablet punching machine.
DOSE: 1.5g (750mg 2 tablets at night)
ANUPAN: Koshnajal (Warm Water)
SOP
OF PREPARATION OF JATAMANASI VATI:-
Raw material for Jatamanasi will be purchased from
authentic pharmaceutical company. The authentication of drug will be performed
from Department of Dravyaguna school of Ayurveda, Nerul Navi Mumbai. The vati
will be formed in the terms of tablets through authentic GMP certified company
and the standardization of raw drugs and tablet formed will be done from
certified company. The authentic raw Jatamanasi will be taken followed by
Pulverisation to make it into powder form. Starch, gum acacia will be added as Binder to make
granules with binder. Further the mixture will allow to dry in a tray dryer.
Eventually equal size of granules will be prepare by granulator & tablet
will be made by tablet punching machine.
DOSE: 1.5g (750mg 2 tablets at night)
ANUPAN: Koshnajal (Warm Water)
|