| CTRI Number |
CTRI/2024/07/070191 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Mahakalyanaka Ghrita and Panchagavya Ghrita in Generalized Anxiety Disorder and its Medical Astrology |
|
Scientific Title of Study
|
A Clinical and Comparative Study to Evaluate the Effect
of Mahakalyanaka Ghrita and Panchagavya Ghrita in the
Management of Chittodvega and its Medical Astrology
Correlates |
| 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 Singh Divya |
| Designation |
Phd Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of AYURVEDA IMS BHU
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7776955534 |
| Fax |
|
| Email |
divyasingh.1312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof KHHVSS Narasimha Murthy |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of AYURVEDA IMS BHU
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415813567 |
| Fax |
|
| Email |
k_narasimhamurthy@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof KHHVSS Narasimha Murthy |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of AYURVEDA IMS BHU
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415813567 |
| Fax |
|
| Email |
k_narasimhamurthy@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital Faculty of Ayurveda Institute of Medical Sciences BHU Varanasi |
|
|
Primary Sponsor
|
| Name |
Sir Sunderlal Hospital Department of Kayachikitsa Faculty of Ayurveda |
| Address |
Institute of Medical Sciences Banaras Hindu University Varanasi
Uttar Pradesh 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 Singh Divya |
Sir Sunderlal Hospital Institute of Medical Sciences, Banaras Hindu University |
OPD No. 23, Manas Roga,
Department of Kayachikitsa,
Ayurveda wing, Institute of Medical Sciences, Banaras
Hindu University, Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
7776955534
divyasingh.1312@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahakalyanaka Ghrita, Reference: Ashtang Hridaya Uttarsthana 6/26-34, AFI page no. 94., Route: Oral, Dosage Form: Ghrita, Dose: 24(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Panchagavya Ghrita, Reference: Ashtang Hridaya Uttarsthana 7/18-19, AFI page no. 90., Route: Oral, Dosage Form: Ghrita, Dose: 24(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: warm water), Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | | - | Escitalopram | Dose-10mg, Route of Administration-Oral, Frequency-OD, Duration- 2 Months. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria of DSM- V for Generalized Anxiety Disorder
and willing to sign the informed consent.
A. Excessive anxiety and worry (apprehensive expectation), occurring more days than
not for at least 6 months, about a number of events or activities (such as work or school
performance).
B. The individual finds it difficult to control the worry.
C. The anxiety and worry are associated with three (or more) of the following six symptoms (with at least some symptoms having been present for more days than not for the
past 6 months):
1. Restlessness or feeling keyed up or on edge.
2. Being easily fatigued.
3. Difficulty concentrating or mind going blank.
4. Irritability.
5. Muscle tension.
6. Sleep disturbance (difficulty falling or staying asleep, or restless, unsatisfying
sleep).
D. The anxiety, worry, or physical symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.
E. The disturbance is not attributable to the physiological effects of a substance (e.g., a
drug of abuse, a medication) or another medical condition (e.g., hyperthyroidism).
F. The disturbance is not better explained by another mental disorder. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from other Anxiety Disorders like- Separation Anxiety Disorder,
Social Anxiety Disorder, Specific Phobia, Panic Disorders.
2. Patients suffering from Substance or Medication Induced Anxiety.
3. Patients suffering from other psychiatric disorders like Depression, Bipolar Disorder.
4. Pregnant women. |
|
|
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 |
Relief in sign and symptoms of the disease
The main sign and symptoms in the study are as
follows
1. Excessive Worry
2. Restlessness
3. Easily Fatigued
4. Difficulty in Concentration
5. Irritability
6. Muscle Tension
7. Sleep Disturbance
8. Depressed Mood
9. Diminished Interest/ Pleasure
10. Significant Weight Loss
11.Insomnia/Hypersomnia
12. Psychomotor Agitation/Retardation
13. Fatigue
14. Worthlessness/Guilt
15. Diminished Concentration
16. Recurrent Suicidal Ideation
Astrological appearance of Graha, Mahadasha, Antardasha in Lagna Chart in Horoscope of patients with Chittodvega will be studied.
|
60 days study with follow up of every 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of scoring of following scales
1.Symptom Rating Scale
2.Hamilton Anxiety Rating Scale |
60 days study with follow up of every 30 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 4 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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
|
150 clinically diagnosed patients of Chittodvega (Generalised Anxiety Disorder) will be registered and divided randomly into three groups with 50 patients in each group and following interventions will be done:
Group I (Control Group): Escitalopram 10mg
Group II: Mahakalyanaka Ghrita 24 grams
Group III: Panchagavya Ghrita 24 grams
|