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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  
Name  Address 
nil  nil 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: अनिद्रा,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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: -
2Comparator ArmDrugClassical(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)


 
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