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CTRI Number  CTRI/2023/05/052655 [Registered on: 15/05/2023] Trial Registered Prospectively
Last Modified On: 11/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Shirodhara]  
Study Design  Single Arm Study 
Public Title of Study   Clinical study to see the efficacy of kushmanda ghrita and shirodhara with Brahmi taila in the management of Anidra(Insomnia) 
Scientific Title of Study   Study the efficacy of kushmanda ghrita and shirodhara with Brahmi taila 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  Jahanara Parbin Ahmed 
Designation  Postgraduate Scholar  
Affiliation  Government Ayurvedic College and hospital Jalukbari Guwahati kamrup Assam India  
Address  Government Ayurvedic College and hospital Jalukbari Guwahati kamrup Assam India Department of kayachikitsa Government Ayurvedic College and hospital Jalukbari Guwahati kamrup Assam India 781014

Kamrup
ASSAM
781014
India 
Phone  7002797493  
Fax    
Email  jahanaraahmed1993@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrRanjan Kumar kalita 
Designation  Assistant professor, kayachikitsa Deptt Govt Ayurvedic college& hospital Jalukbari Guwahati-14  
Affiliation  Government Ayurvedic College and hospital Jalukbari Guwahati kamrup Assam India  
Address  Department of kayachikitsa Government Ayurvedic College and hospital Jalukbari Guwahati kamrup Assam India 781014

Kamrup
ASSAM
781014
India 
Phone  8011566721  
Fax    
Email  ranjankalita1972@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrRanjan Kumar kalita 
Designation  Assistant professor, kayachikitsa Deptt Govt Ayurvedic college& hospital Jalukbari Guwahati-14  
Affiliation  Government Ayurvedic College and hospital Jalukbari Guwahati kamrup Assam India  
Address  Department of kayachikitsa Government Ayurvedic College and hospital Jalukbari Guwahati kamrup Assam India 781014

Kamrup
ASSAM
781014
India 
Phone  8011566721  
Fax    
Email  ranjankalita1972@gmail.com  
 
Source of Monetary or Material Support  
Jahanara Parbin Ahmed Department of kayachikitsa Government Ayurvedic College and hospital Jalukbari Guwahati kamrup Assam India  
 
Primary Sponsor  
Name  Jahanara Parbin Ahmed 
Address  Department of kayachikitsa Government Ayurvedic College and hospital Jalukbari Guwahati kamrup Assam India  
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 
DrRanjan Kumar kalita  Government Ayurvedic College and hospital Jalukbari Guwahati kamrup Assam India   OPD and IPD of department of kayachikitsa Government Ayurvedic College and hospital Jalukbari Guwahati kamrup Assam India 781014
Kamrup
ASSAM 		 8011566721

ranjankalita1972@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE Government Ayurvedic College and hospital Jalukbari Guwahati kamrup Assam India   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F01-F99||Mental, Behavioral and Neurodevelopmental disorders. Ayurveda Condition: Anidra(Insomnia), ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-6 (Procedure Reference: Bhavaprakash nighantu, chaukhambha Varanasi, Ayurveda sharsangraha Sri Baidyanath Ayurved Bhavan , Procedure details: Shirodhara with Brahmi taila for duration of 7days)
(1) Medicine Name: Kushmanda Ghrita , Reference: Bhaisajya ratnavali chapter 25 Apasmar chikitsa, Sharangadhar samhita madhyam khanda 9:12-14:116, Route: Oral, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Male and female patients of age group between 18-70years
2.Patients who are willing to sign informed consent form.
3.Patients having classical features of Anidra like angamarda,sirogaurava,glani,bhrama, tandra ,apakti.
4.Patients with Athens insomnia scale>6 and Pittsburgh sleep Quality index>5 
 
ExclusionCriteria 
Details  1.Age below 18years and above 70years.
2.Associated with major diseases like malignancy, epilepsy, schizophrenia,renal failure,severe hypertension, uncontrolled Diabetes mellitus.
3.Pregnant lady and lactating mother.
4.Allergy to the medication. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Decrease in sign and symptoms like angamarda, sirogaurava,glani, bhrama, tandra,apakti  30days 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in Athens insomnia scale and Pittsburgh sleep Quality index   30days 
 
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   Phase 2 
Date of First Enrollment (India)   20/05/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jahanaraahmed1993@gmail.com].

  6. For how long will this data be available start date provided 18-09-2021 and end date provided 01-03-2024?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This trial will be carried out in 60 patients within a duration of  30days to study the efficacy of Kushmanda ghrita and shirodhara with Brahmi taila in the management of Anidra(Insomnia). 
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