| CTRI Number |
CTRI/2020/01/022793 [Registered on: 15/01/2020] Trial Registered Prospectively |
| Last Modified On: |
16/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Research Study of effect of Ayurvedic Drugs on School pressure or tentions in School Children |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial on the Efficacy of
Ashwagandhadi Compound on Academic Stress
in School Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not registered anywhere |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nilesh Manohar Ingle |
| Designation |
Assistant Professor |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya, Amravati |
| Address |
OPD no.11,Kaumarbhritya Department, Vidarbha Ayurved Mahavidyalaya and hospital, Dhanwantari nagar, Chatri Talao Road, Amravati
Amravati
MAHARASHTRA
444606
India |
| Phone |
|
| Fax |
|
| Email |
drimnileshphd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravat Kumar Dash |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurvedic College PGTRC, Kodoli |
| Address |
OPD No.07, Kaumarbhritya Department, Yashwant Ayurvedic College PGTRC, Kodoli Tal-Panhala Dist-Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277590 |
| Fax |
|
| Email |
drpkdash25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravat Kumar Dash |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurvedic College PGTRC, Kodoli |
| Address |
OPD No.07, Kaumarbhritya Department, Yashwant Ayurvedic College PGTRC, Kodoli Tal-Panhala Dist-Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277590 |
| Fax |
|
| Email |
drpkdash25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College PGTRC Kodoli |
|
|
Primary Sponsor
|
| Name |
Yashwant Ayurvedic College PGTRC Kodoli |
| Address |
At Kodoli Tal-Panhala
Dist-Kolhapur |
| Type of Sponsor |
Other [Private Ayurvedic 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 Nilesh Manohar Ingle |
Gopal Nanji Tank Hospital, Amravati |
OPD No. 11, Department of Kaumarbhritya, Dhanwantari nagar, Chatri Talao road, Amravati-444606
Amravati
MAHARASHTRA |
9822648179
drimnileshphd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Yashwant Ayurvedic College, PGTRC, Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
School Going Children Suffering From Academic Stress |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandhadi Compound with psychotherapy |
200 mg per kg body weight in the form of granules with milk for 3 months. |
| Comparator Agent |
Placebo Compound with Psychotherapy |
200 mg per kg body weight in the form of granules with milk prepared from starch of same colour and texture (like intervention drug) for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Children showing manifestations of stress as indicated from the scores of AASC and DSM V criteria.
2.Children with poor school performance from previous school record.
3.Children who are physically and mentally healthy.
4.Children & parents who are consciously willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
· Children below 15 years and above16 years of age.
· Children with physical & mental disability.
· Children with any chronic systemic illness.
· Children suffering from developmental disorders.
· Children with post-traumatic stress.
· Children with any genetic disorder.
· Children having congenital anomalies.
· Obsessive compulsive disorder.
· Children & parents who are consciously not willing to participate in study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Efficacy of Ashwagandhadi Compound on academic stress in school children.
2.Study the impact of academic stress on academic performance of school children.
|
At the end of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
· To compare effectiveness of Aswagandhadi Compound with
Psychotherapy in managing academic stress.
· To establish Ayurvedic pathogenesis of academic stress on the basis of
Ayurvedic principles and available literature.
· To estimate the prevalence of academic stress in school children in study
area. |
At the end of 3 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "153"
Final Enrollment numbers achieved (India)="153" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/01/2020 |
| Date of Study Completion (India) |
18/09/2021 |
| 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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Current Study is the double blind randomized controlled clinical trial. Purpose of Study:As the world is advancing with its speed the level of stress in school children is increasing day by day. Stress cannot be exempted from school children and thereby the academics. If this stress is not well managed may prove to be detrimental in terms of poor academic performance, poor concentrations, and health problems.Despite of these deleterious effects the academic stress is less researched. Current therapies available for the management of stress are effective but the problem of tolerance and physical dependence on their prolonged use, limits the clinical utility of these drugs. Moreover previous researches conducted so far are limited to demographic evaluation of data. In addition to this school children are not the target population in most of the cases. Adolescents with severe academic stress need to be identified early as interventions to reduce academic stress are likely to affect the occurrence and severity of depression. Present research is design with objective to provide a novel and therapeutically effective herbal composition with proven pharmacological activities without any side effects. Hence this trial is aimed at establishing the role of herbal formulations in academic stress. With this view in mind following clinical trial entitled as "A Randomized Controlled Clinical Trial To Evaluate The Effect Of Ashwagandhadi Granules On Academic Stress In School Children." is proposed for the study |