FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/12/011021 [Registered on: 28/12/2017] Trial Registered Prospectively
Last Modified On: 27/12/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare efficacy of some herbal drugs in the managment of Chittodvega (Generalized Anxiety Disorder). 
Scientific Title of Study   A Clinical Study to Evaluate the Safety and Efficacy of Brahmi Ghrita and Shankhapushpi Panak in the Management of Chittodvega with special reference to Generalized Anxiety Disorder. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Ram Kishor Joshi 
Designation  Professor & Head of Department 
Affiliation  National Institute of Ayurveda 
Address  PG Department of Kayachikitsa National Institute of Ayurveda Jorawar Singh Gate , Madhav Villas Palace , Amer Road

Jaipur
RAJASTHAN
302002
India 
Phone  9414322297  
Fax    
Email  joshirk1964@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Ram Kishor Joshi 
Designation  Professor & Head of Department 
Affiliation  National Institute of Ayurveda 
Address  PG Department of Kayachikitsa National Institute of Ayurveda Jorawar Singh Gate , Madhav Villas Palace , Amer Road
Jorawar Singh Gate Madhav Villas Palace, Amer Road

RAJASTHAN
302002
India 
Phone  9414322297  
Fax    
Email  joshirk1964@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shriti Agrawal 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda 
Address  PG Department of Kayachikitsa National Institute of Ayurveda Jorawar Singh Gate , Madhav Villas Palace , Amer Road

Jaipur
RAJASTHAN
302002
India 
Phone  8960587141  
Fax    
Email  shriti2490@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Madhav Vilas Palace, Amer Road, Jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Jorawar Singh Gate, Madhav Villas Palace, Amer Road 
Type of Sponsor  Research institution and hospital 
 
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 
Prof Ram Kishor Joshi  National Institute of Ayurveda  P.G.Department Of Kayachikitsa,Jorawar Singh Gate, Madhav Villas Palace, Amer Road
Jaipur
RAJASTHAN 
9414322297

joshirk1964@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, NIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chittodvega (Genearalized Anxiety Disorder),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brahmi Ghrita   Brahmi Ghrita in dose of 10 gm with luke warm water as Anupana after meals twice a day orally for 30 days 
Comparator Agent  Shankhapuspi Panak  Shankhapushpi Panak in dose of 15 ml with equal amount of water after meals twice a day orally for 30 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient willing to sign the consent form.
2. Patients of either sex with age between 18 to 60 years.
3. Patient fulfilling the Diagnostic and Statistical Manual of Mental Disorder , Fourth Edition (DSM – IV).
4. Patient who score at least 14 on the Hamilton Anxiety Rating Scale (HARS – A) at baseline visit.
 
 
ExclusionCriteria 
Details  1.Chittodvega is due to direct physiological effect of a substance (e.g. A drug abuse, a medication ) or a general medical condition (e.g. Hyperthyroidism).
2.Occurence of Chittodvega exclusively during mood disorder, a psychotic disorder or a pervasive development disorder.
3.Patients having chronic diseases like Diabetes Mellitus, Ischemic Heart Disease, Dyslipidaemia, Hypertension, Malignancies, Chronic Renal Failure, any Endochrinological disorders etc. will be excluded.
4.Patients who have completed participation in any other clinical trial during the past six months.
5.Pregnant or lactating women.
6.Any other condition which the Investigator thinks may jeopardize the study.
7.Patients receiving Anxiolytic Drugs will be excluded.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Patients of either sex 18 to 60 years old diagnosed as Chittodvega (Generalized Anxiety Disoredr) will be selected for relief in sign and symptoms.  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
To compare efficacy of Brahmi Ghrita and Shankhapushpi Panak in the management of Chittodvega (Generalized Anxiety Disorder).   30 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)   20/08/2018 
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   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Ayurveda, the science of life, is the supreme theory with unerring factors based on Tridosha and Panchabhautic principles. This system, with its eight divisions, encompassed every angle of a person’s health, ailments and treatments which were highly comprehensive. Ayurveda, though ancient, but still contemporary and potential enough to deal the diseases of present era. Chittodvega is Manas Roga and develops due to vitiation of Raja and Tama. Chittodvega can be defined as a Chitta (mind) + Udvega (anxiety) i.e. ‘Anxious status of a mind”. Nidana Sevana aggravates Raja, which further aggravates Tama along with Vata and Pitta.  Chittodvega is one of the minor psychological disorders (no disorientation as the patient can perform his/her day to day activities without much difficulty i.e. neurosis) and neurosis may develop psychosis. It can be correlated with Generalized Anxiety Disorder on the basis of etymology of Chittodvega (anxious state of mind), type of psychological disorder (neurotic Disorder) and symptomology (both are psychosomatic disorder). Generalized Anxiety Disorder  present with persistent, excessive, and/or unrealistic worry associated with muscle tension, impaired concentration, autonomic arousal, feeling "on edge" or restless, and insomnia . In present era, the occurrence of many diseases has increased and one of them is mental disorder, which is mentioned as 3rd health burden in India according WHO survey. Current estimate suggest that 6.8 million adult worldwide suffer from Generalized Anxiety Disorder. According to a survey in India of total sample sample size of 33,572 yielded an estimated prevalence rate of 20.7% for all neurotic disorders, the weighted prevalence rate of Generalized Anxiety Disorder is 5.8% (ref an overview of indian research in anxiety disorders).  The modern medical treatment of this disease requires long term use of sedative, hypnotic and anxiolytic drugs, which may lead to various side effects and affects the quality of life of the patient. But the treatment should cure the disease without developing any other disease. So, there is a need of better treatment with less complications.In Chittodvega, there is a vitiation of Vata and Pitta along with Rajas and Tama. The treatment should be of Vatahara and Pittahara  along with  Medhya Prabhava. Therefore, the drugs with the above said qualities are needed for alleviating the symptoms of Chittodvega.  Keeping all above points in mind, the two compound drugs Brahmi Ghrita and Shankhapushpi Panak have been selected to know their effect in treating Chittodvega (Generalized Anxiety Disorder). Brahmi Ghrita is described in Bhava Prakasha under ‘Apasmaradhikara ’; contains Brahmi, Shankhapushpi, Vacha, Kustha and Goghrita. Brahmi is Tridoshshamaka and has Medhya Prabhava, Secondly; Shankhapushpi Panak is described in Ayurveda Sara Sangraha, under ‘Panak Kalpana’, containing Shankhapushpi, Brahmi and Sharkara. Shankhapushpi is Tridoshshamaka especially Vata-Pittashamaka and has Medhya Prabhava.The drugs are to be administered orally. The contents of the drugs are cheap and easily available so the treatment cost is minimal and can be afforded even by poor patients.

 
Close