| CTRI Number |
CTRI/2024/09/073969 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of Brahmi Tail Nasya and Yoga module in Chittodvega |
|
Scientific Title of Study
|
Randomized Comparative Clinical Evaluation Of Brahmi Taila Nasya And Yoga Module in Chittodvega (Generalized Anxiety Disorder) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Kumar Sharma |
| Designation |
Professor |
| Affiliation |
Uttarakhand Ayurved University,Rishikul Campus,Haridwar |
| Address |
Department of Panchkarma,Rishikul Campus, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9758264264 |
| Fax |
|
| Email |
kripayanam@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Kumar Sharma |
| Designation |
Professor |
| Affiliation |
Uttarakhand Ayurved University,Rishikul Campus,Haridwar |
| Address |
Department of Panchkarma,Rishikul Campus, Haridwar
UTTARANCHAL
249401
India |
| Phone |
9758264264 |
| Fax |
|
| Email |
kripayanam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shiwani Manral |
| Designation |
PG Scholar |
| Affiliation |
UAU,Rishikul Campus,Haridwar |
| Address |
OPD No. 20,Department of Panchkarma, Rishikul Campus Haridwar, Uttarakhand Ayurved University,
India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7895636890 |
| Fax |
|
| Email |
manralshiwani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchkarma,Rishikul Campus,Uttarakhand Ayurved University,Haridwar, 249401, India |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University,Harrawala,Dehradoon, Uttarakhand
248001, INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Shiwani manral |
Rishikul Ayurvedic hospital |
OPD No. 20, Department of Panchkarma,Uttarakhand ayurved university ,rishikul campus haridwar
Uttarakhand, 249401, India
Hardwar
UTTARANCHAL |
7895636890
manralshiwani@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: ANAVASTHITACITTATVAMÂ (KEVALAVATA), (2) ICD-10 Condition:G||Mental Health. Ayurveda Condition: ANAVASTHITACITTATVAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtang Hridaya Sutrasthan, Procedure details: nasya karma with oil)
(1) Medicine Name: Brahmi Tail, Reference: Ayurveda Saar Sangrah, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | YOGA MODULE | PRANAYAMA-
Nadi-suddhi Pranayama(5min)
Anuloma Viloma Pranayama (5min)
Bhramri evam Bhastrika Pranayama (5min)
SUKSHMA VYAYAMA (15 min)
Surya Namaskar
Shashanka Asana
OM CHANTING & YOGA NIDRA
OM Chanting – 5min
Yoga Nidra- 10min |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient fulfilling DSM 5 ,diagnostic criteria for GAD
Age group between 20-50 years
Gender-Irrespective of gender
Patient fit for Nasya and Yoga
Willing to give written consent |
|
| ExclusionCriteria |
| Details |
Patient presenting with major illness and psychotic disorders
Uncontrolled cases of hypertension
Uncontrolled cases of type 1 and type 2 diabetes mellitus
Severe cardiac diseases like MI,CAD,IHD
Pregnant women
Not willing to give written consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
complete remission-100% relief
Markedly improvement-76-99% relief
Moderately improvement-51%-75% relief
Mild improvement-26-50% relief |
At Baseline, 4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of sign and symptoms |
31 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Generalized anxiety disorder (GAD) is a mental health disorder that
produces fear, worry and a constant feeling of being overwhelmed. It is
characterized by excessive, persistent and unrealistic worry about everyday
things. A wide range of psychiatric
conditions have been described in Ayurveda. Ayurveda follows
psychosomatic approach of health. According to Ayurveda psychic factors
are involved in almost all the disease processes along with physical
disturbance as both are interdependent. Mind is one of the substratums of
diseases and having its own Doshas (Rajasa and Tamasa).
Many psychological conditions caused by these Doshas like-Kama
(passion), Krodha(anger), Lobha (greed), Moha (confusion),
Irshya (envy), Mana (conceit), Mada (arrogance), Chittodvega
(anxiety), Bhaya (fear), Harsha (exhilaration) etc.
Chittodvega is a Manas Vikara mentioned by Charaka which
is considered as a perfect word for highlighting the status of anxiety, Generalized
Anxiety Disorder. Chittodvega can exists as a separate disease or can be
an etiological factor for other psychic and psychosomatic diseases.Being an alarming disease,
it requires effective management. In recent years several synthetic drugs have
been introduced for the treatment of anxiety disorders. Though these drugs have
better results but one cannot avoid major side effects such as drug dependence,
drug resistance, sedation etc. Nasya Karma is the main therapeutic measure of Urdhva
Jatrugata Roga. Chittodvega is a Mansik Vikara.
Mana is said to be located between Shirah and Talu. All organs,
which are above the clavicle, are considered as Urdhvanga e.g., Nasa ,Mukha,
Netra and Shirah, without Nasya Karma it is not possible to
eliminate the vitiated Doshas, which are situated in the Shirah
or Nasa etc. Hence Nasya therapy would
have significant role in the treatment of the Chittodvega. Yoga reduces
stress and anxiety by improving autonomic functions via triggering
neurohormonal mechanisms that suppress sympathetic activity through
downregulation of the hypothalamic–pituitary–adrenal (HPA) axis. Hence Nasya and Yoga module are selected for the present study. |