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CTRI Number  CTRI/2021/09/036371 [Registered on: 09/09/2021] Trial Registered Prospectively
Last Modified On: 21/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Role of drug "Tagaradi kwath" in the management of Anidra (Insomnia) 
Scientific Title of Study   A Clinical study to evaluate the Therapeutic effect of drug "Tagaradi kwath" in the management of Anidra (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 Sanjay singh 
Designation  MD-Scholar 
Affiliation  Shubhdeep Ayurved Medical College And Hospital P.G Institute 
Address  Shubhdeep Ayurved Medical College And Hospital P.G Institute Village-Datoda,Khandwa Road, Indore(M.P.)
Village-Datoda,Khandwa Road, Indore(M.P.)
Indore
MADHYA PRADESH
452020
India 
Phone  9044836602  
Fax    
Email  sskrishna303@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A K Singh 
Designation  professor 
Affiliation  Shubhdeep Ayurved Medical College And Hospital P.G Institute 
Address  Shubhdeep Ayurved Medical College And Hospital P.G Institute Village-Datoda,Khandwa Road, Indore(M.P.)
Village-Datoda,Khandwa Road, Indore(M.P.)
Indore
MADHYA PRADESH
452020
India 
Phone  9300681233  
Fax    
Email  doctoraksingh@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Umesh Patil 
Designation  Assistant professor 
Affiliation  Shubhdeep Ayurved Medical College And Hospital P.G Institute 
Address  Shubhdeep Ayurved Medical College And Hospital P.G Institute Village-Datoda,Khandwa Road, Indore(M.P.)
Village-Datoda,Khandwa Road, Indore(M.P.)
Indore
MADHYA PRADESH
452020
India 
Phone  9826052986  
Fax    
Email  umeshpatil0704@gmail.com  
 
Source of Monetary or Material Support  
Dr Sanjay Singh 
 
Primary Sponsor  
Name  Self 
Address  Shubhdeep Ayurved Medical College And Hospital Indore 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nill   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay singh  Shubhdeep ayurved medical college and hospital   Village-Datoda,Khandwa Road, Indore(M.P.)
Indore
MADHYA PRADESH 		 9044836602

sskrishna303@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F510||Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: TAGARADI KWATH, Reference: YOG RATNAKAR, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: hs, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: 5gm of kwath boiled with 200ml of water when it reduce to 50ml then it will filter after filtration it will take orally for 30 days of time of period at bed time
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patient of Anidra suffering upto 3 months of duration.
2)Nidranasha(Insomnia) according to Athens Insomnia Scale.
3)Patient without any complication of other disease will include in this study. 
 
ExclusionCriteria 
Details  1)Anidra due to other conditions such as madatyaya,abhighata and othervsystemic diseases.
2)Patients on hypnotic medicine or other drugs known to cause drowsiness.
3)Patients with acute illness like myocardial infraction, congestive cardiac failure,COPD,meningitis,acute pain condition and similar other disease.
4)Patients with major psychiatric illness like epilepsy,schizophrenia,major depressive psychosis etc.
5)Patients having chronic disease like liver cirrhosis,asthma,malignancies,diabetes,hypertension and chronic renal failure  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Relief in Angmarda
2)Relief in Sirogaurava
3)Relief in jrumbha
4)Relief in jadyata
5)Relief in bhrama
6)Relief in tandra 		 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
nill  nill 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   23/10/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 IRJAY 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  nill

  6. For how long will this data be available start date provided 08-12-2022 and end date provided 08-12-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nill
Brief Summary
Modification(s)  		 Insomnia is a common sleep disorder or having trouble falling asleep and staying asleep. Nidranasha, an imbalance in Tarpaka Kapha, Sadhaka Pitta and Prana Vayu.  Anidra is vata nanatmaja vyadhi and also as a symptom in various physical and psychological disorders. Study design in this study is randomized and interventional study. Sample size in this study is 30 subjects with in 1 group. Route of administration of drug is orally at night after meal in 50ml of quantity. Total time period of this study is 1 month and follow up period in every 15 days. Final assessment of result is made on the basis of subjective and objective criteria. Appropriate statistical tests will be applied for subjective and objective parameters obtained. 
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