| CTRI Number |
CTRI/2021/12/038431 [Registered on: 03/12/2021] Trial Registered Prospectively |
| Last Modified On: |
03/12/2022 |
| 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
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASHTANGA GHRITA IN THE MANAGEMENT OF CHITTODVEGA WITH SPECIAL REFERENCE TO GENERALIZED ANXIETY DISORDER. |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABELLED CONTROLLED CLINICAL STUDY TO
EVALUATE THE EFFICACY OF ASHTANGA GHRITA 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 |
Dr Tara B |
| Designation |
SECOND YEAR PG SCHOLAR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
DEPARTMENT OF PG STUDIES IN KAYACHIKITSA
ROOM NO 304
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH
21ST KM KANAKAPURA ROAD UDAYAPURA P O BENGALURU
Bangalore
KARNATAKA
560082
India |
| Phone |
8078302028 |
| Fax |
|
| Email |
taara.b003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopala Krishna G |
| Designation |
PROFFESOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
DEPARTMENT OF PG STUDIES IN KAYACHIKITSA
ROOM NO 304
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH
21ST KM KANAKAPURA ROAD UDAYAPURA P O BENGALURU
Bangalore
KARNATAKA
560082
India |
| Phone |
9448173128 |
| Fax |
|
| Email |
lakshmimp1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr TARA B |
| Designation |
SECOND YEAR PG SCHOLAR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL |
| Address |
DEPARTMENT OF PG STUDIES IN KAYACHIKITSA
ROOM NO 304
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH
21ST KM KANAKAPURA ROAD UDAYAPURA P O BENGALURU
Bangalore
KARNATAKA
560082
India |
| Phone |
8078302028 |
| Fax |
|
| Email |
taara.b003@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Dr TARA B |
| Address |
PG SCHOLAR
DEPARTMENT OF PG STUDIES IN KAYACHIKITSA
ROOM NO 304
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH
21ST KM KANAKAPURA ROAD
UDAYAPURA P O |
| Type of Sponsor |
Other [SELF] |
|
|
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 TARAB |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL |
ROOM NUMBER 05, DEPARTMENT OF KAYACHIKITSA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, 21ST KM, KANAKAPURA ROAD, UDAYAPURA POST, BANGALORE, KARNATAKA
Bangalore
KARNATAKA |
8078302028
taara.b003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETICAL COMMITTIE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: CITTODVEGA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ASHTANGA GHRITA |
A CLASSICAL AYURVEDA FORMULATION FROM ASHTANGA HRIDAYA WITH INGRIDIENTS VACHA INDHULEKHA BRAHMI MANDOOKAPARNI SHANKAPUSHPI SHATAVARI VRIDHADARUKA AMRITA COW GHEE COW MILK
10ML-0-10ML IN EMPTY STOMACH, FOLLOWED BY WARM WATER. FOR 30 DAYS, FOLLOW UP ON 15TH DAY AND 45TH DAY, TOTAL STUDY PERIOD 45 DAYS |
| Comparator Agent |
KUSHMANDADI GHRITA |
A CLASSICAL AYURVEDA FORMULATION MENTIONED IN APASMARA CHIKITSA WITH INGRIDIENTS KUSHMANDA, YASHTIMADHU AND COW GHEE
10 ML-0-10ML IN EMPTY STOMACH, FOLLOWED BY WARM WATER. FOR 30 DAYS, FOLLOW UP ON 15TH DAY AND 45TH DAY TOTAL STUDY PERIOD 45 DAYS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.SUBJECTS SUFFERING FROM GENERALIZED ANXIETY DISORDER BETWEEN AGE GROUP OF 20 TO 60 YEARS IRRESPECTIVE OF GENDER SOCIO ECONOMIC STATUS AND RELIGION. 2.SUBJECTS PRESENTING WITH PROMINENT TENSION WORRY AND FEELINGS OF APPREHENSION ABOUT EVERY-DAY EVENTS AND PROBLEMS FOR A MINIMUM PERIOD OF AT LEAST SIX MONTHS. 3.SUBJECTS FULFILLING CRITERIA BASED ON ICD 10 F41 1 CLASSIFICATION OF MENTAL AND BEHAVIOURAL DISORDERS CODE F41 1 AND THOSE GET SCORE BETWEEN 14-24 IN HAMILTON ANXIETY RATING SCALE MILD 14-17 AND MODERATE 18-24 WILL BE INCLUDED IN THE STUDY.
|
|
| ExclusionCriteria |
| Details |
1. SUBJECTS SUFFERING FROM PANIC DISORDER F41 PHOBIC ANXIETY DISORDERS F40
OBSESSIVE-COMPULSIVE DISORDER F42 AND HYPOCHONDRIACAL DISORDER F45 2
2. SUBJECTS SUFFERING FROM OTHER PSYCHIATRIC ILLNESSES LIKE MOOD DISORDER, PSYCHOSIS,
EPILEPSY.
3. SUBJECTS SUFFERING FROM GENERALIZED ANXIETY DISORDER ASSOCIATED WITH OTHER SERIOUS
ILLNESSES THAT WOULD INTERFERE WITH THE TREATMENT.
4. SUBJECTS SUFFERING FROM HYPERTHYROIDISM, ORGANIC MENTAL DISORDER OR PSYCHOACTIVE
SUBSTANCE-RELATED DISORDER F1 SUCH AS EXCESS CONSUMPTION OF AMPHETAMINE-LIKE
SUBSTANCES, OR WITHDRAWAL FROM BENZODIAZEPINES.
5. SUBJECTS WHO ARE ALREADY TAKING ALLOPATHIC MEDICATION FOR GENERALISED ANXIETY
DISORDER.
6. PREGNANT AND LACTATING MOTHERS.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN HAMILTON ANXIETY RATING SCORE |
45 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN SYMPTOMS OF ANXIETY LIKE PROMINENT TENSION, EXCESSIVE WORRY, FEELING OF APPHREHENSION IN DAY TO DAY EVENTS AND PROBLEMS |
REDUCTION IN SYMPTOMS ON 15TH, 30TH AND 45TH DAY |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/12/2021 |
| Date of Study Completion (India) |
17/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
THIS STUDY IS PUT FORWARD TO EVALUATE THE EFFICACY OF ASHTANGA GHR |