| CTRI Number |
CTRI/2026/01/101885 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to See How Guduchi Modak improves Mental Stress and Emotional Problems in Adolescent Girls of age 12–19 Years. |
|
Scientific Title of Study
|
Study on effect of Guduchi modak in Psychological Distress in adolescent
girls of age 12 to 19 years: a Double-blind, Randomized, Prospective,
Parallel group, Placebo controlled clinical trial |
| 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 Simranjeet Kaur Rolla |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG department of Kaumarbhritya, National Institute of Ayurveda, Madhav Vilas Palace, Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9351524620 |
| Fax |
|
| Email |
simmi9351524620@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Nisha Kumari Ojha |
| Designation |
HOD and Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kaumarbhritya, National Institute of Ayurveda,
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9468650449 |
| Fax |
|
| Email |
drnishaojha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Nisha Kumari Ojha |
| Designation |
HOD and Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kaumarbhritya, National Institute of Ayurveda,
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9468650449 |
| Fax |
|
| Email |
drnishaojha@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Amer road, Jaipur, 302002, Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda, Madhav Vilas palace, Amer Road, Jaipur, 302002, Rajasthan, 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 Simranjeet Kaur Rolla |
National Institute of Ayurveda Hospital |
OPD no. 5, Balroga Department, National Institute of Ayurveda Hospital, Jaipur
Jaipur
RAJASTHAN |
9351524620
simmi9351524620@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F413||Other mixed anxiety disorders. Ayurveda Condition: KAPAJA-UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Placebo | Chocolate coated Sugar and Starch Modak | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchi Modak, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Modaka , Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
Adolescents of age between 12 to 19 years.
Adolescents having signs and symptoms of psychological distress (according to scale).
Overtly healthy adolescents.
Adolescents whose parents are wiling to give consent for clinical trial.
|
|
| ExclusionCriteria |
| Details |
Any past history of diagnosed mental illness.
Any severe mental illness requiring hospitalization.
Adolescents suffering from major systemic illness necessitating long term treatment like, Known Case of Anemia, Hypothyroidism and Juvenile Diabetes mellitus.
H/o hypersensitivity to any drug.
Adolescents whom parents are not wiling to give consent for clinical trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in SDQ(Strengths and Difficulties Questionnaire )score |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in youth quality of life. |
12 weeks |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2026 |
| 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 Applicable |
| 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
|
1.INTRODUCTION
Adolescence is
a transitional phase of growth and development between childhood and adulthood. The word
adolescent comes from the Latin verb adolescent meaning “To grow up. According to
WHO adolescents lies in between 10 -19 yearsof age. Because of the physical,
psychological, and sexual changes that occur during adolescence,
the psychiatric complaints like depression, anxiety, and stress occurs during
this phase of life
is a cause for alarm. The world’s highest population of adolescents live in
India that is 253
million and every 5th individual is in the middle of 10 to 19 years. In
adolescent the term
psychiatric morbidity is defined as abnormality in relationship, emotions,
general behaviour and
activity which is developmentally inapt and responsible for persistent
suffering or handicap
the adolescents and/or distress to the households or society. Adolescents experience
psychosocial issues at some point during their growth. The majority of these issues are
temporary and generally go unrecognized. It’s worth noting that adolescents can have these
issues in one situation but not in another (e.g., family, school and friend’s
circle). Consequently,
these psychiatric morbidities are often misinterpreted. They may be measured intentional or
purposefully, their self-esteem may be diminished as a result of social exclusion,
sanctions, and criticism. Children and teenagers may be denied the help they require due to
a faulty and improper understanding of these mental illness. “Adolescence
is a critical period characterized by vulnerability to psychological distress
and is therefore
an important time for promotion of psychological wellbeing and early mental health
intervention, in order to safeguard against the development of mental health
issues. Adolescence is
frequently marked by fresh stress, behavioural changes, relationship issues, which have an
impact on psycho -social development. Adolescent children who have their parents taking
part in their life are better able to deal with challenges and maintain their physical and
emotional wellbeing. High levels of parental participation and the formation of
a close
relationship between children and parents have been linked to lower rates of depression and loneliness
among young people in high-income countries.
2.NEED OF
STUDY
As the
prevalence of mental health problems in adolescents in India is high, with
estimates ranging from
6.5% to 23.3%, it is important to invest in adolescents and to build on Indigenous
ways of child and adolescent health promotion. Adolescents with mental health conditions are
particularly vulnerable to social exclusion, discrimination, stigma (affecting readiness to
seek help), educational difficulties, risk taking behaviours, physical ill
-health and human rights
violations. Modern psychiatry still has limitations to access the diversity of mind and its
functional aspects. Etiopathogenesis of several psychiatric morbidities are
still mysterious,
and contemporary management is often only partially effective along with lots
of adverse
effects. Ayurveda Medhya Rasayana are specifically indicated for maintenance of mental/psychological
well-being. Several studies also certify that these drugs have nootropic as well as
psychotropic effect and work variously to improve the psychological functioning of an
individual. Therefore, it is supposed that these drugs can be beneficial in
this area also. With all these
issues in mind, this study is planned with an intension to know the prevalence of
pshychological distress among adolescents of jaipur so that further
interventions can be done in terms of prevention and promotion of better
health.
3.RESEARCH
QUESTION
Is Guduchi
modak effective in management of psychological distress in adolescent girls?
4.HYPOTHESIS
NULL
HYPOTHESIS (H0)- Guduchi modak
has no effect in the management of psychological distress in adolescent girls.
ALTERNATIVE
HYPOTHESIS (H1)-Guduchi modak
has significant effect in the management of psychological distress in
adolescent girls.
5.AIM
To evaluate
the efficacy of Guduchi modak in the management of Psychological distress in
adolescent girls.
6.OBJECTIVES
Primary
objective
To evaluate
the efficacy of Guduchi modak in the management of Psychological distress in
adolescent girls.
Secondary
objective
To compare the
effect of Guduchi modak and placebo in the management of Psychological distress
in adolescent girls. |