| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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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)?
|
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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 mindâ€. 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. |