| CTRI Number |
CTRI/2026/02/103107 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing effectiveness of Nutrimind-2, a herbal intervention versus a chocolate supplement in reducing anxiety caused due to social media in young participants.
|
|
Scientific Title of Study
|
Comparative efficacy of Nutrimind-2 and Cocoa based supplement in Social media -induced anxiety in young adults : A Randomized Controlled Study. |
| 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 Prajakta Pawar |
| Designation |
MD Scholar |
| Affiliation |
Dr. D.Y Patil College of Ayurved and Research Centre,Pimpri, Pune |
| Address |
Department of Dravyaguna Vigyan Dr. D.Y Patil College of Ayurved & Research Centre Pimpri Pune 411018 Maharashtra India
Department of Dravyaguna Vigyan Dr. D.Y Patil College of Ayurved & Research Centre Pimpri Pune 411018 Maharashtra India
Pune
MAHARASHTRA
411018
India |
| Phone |
9604501211 |
| Fax |
|
| Email |
prajupawar2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijeet Shirkande |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y Patil College of Ayurved & Research Centre,Pimpri, Pune |
| Address |
Department of Dravyaguna Vigyan Dr. D.Y Patil College of Ayurved & Research Centre Pimpri Pune 411018 Maharashtra India
Department of Dravyaguna Vigyan
Dr. D.Y Patil College of Ayurved & Research Centre Pimpri Pune 411018 Maharashtra India
Pune
MAHARASHTRA
411018
India |
| Phone |
9975253664 |
| Fax |
|
| Email |
abhijeet.shirkande@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajakta Pawar |
| Designation |
MD Scholar |
| Affiliation |
Dr. D.Y Patil College of Ayurved and Research Centre,Pimpri, Pune |
| Address |
Department of Dravyaguna Vigyan Dr. D.Y Patil College of Ayurved & Research Centre Pimpri Pune 411018 Maharashtra India
Pune
MAHARASHTRA
411018
India |
| Phone |
9604501211 |
| Fax |
|
| Email |
prajupawar2018@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Prajakta Avinash Pawar |
| Address |
Dr. D.Y Patil College of Ayurved & Research Centre Pimpri, Pune,
Pincode- 411018 Maharashtra India |
| 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 Prajakta Pawar |
Dr. D.Y Patil College of Ayurved & Research Centre, Pimpri, Pune-411018. |
Department of Dravyaguna Vigyan, Dr. D.Y Patil College of Ayurved & Research Centre, Pimpri, Pune-411018 ,Maharashtra, India
Pune
MAHARASHTRA |
9604501211
prajupawar2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Suffering from social media anxiety |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Cocoa supplement | 70 % dark chocolate bar | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Nutrimind-2, Reference: NA, Route: Oral, Dosage Form: , Dose: 15(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: It is a herbal neutraceutical bar |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1. Self-reported active use of social media, defined as engagement exceeding 4 hours per day, corroborated by device-based screen time evidence at the time of screening.
2. Male or female participants, aged 18 to 28 years
3. A score between 2 and 9 on the Social Media Disorder Scale (SMDS).
4. A score between 18 and 24 on the Hamilton Anxiety Rating Scale (HAM-A).
5. Not currently receiving any anxiolytic therapy, including pharmacological or herbal preparations, whether prescription or over-the-counter.
6. Provides written informed consent voluntarily, in accordance with ICH-GCP guidelines and applicable local ethical regulations, prior to the initiation of any study-related procedures.
|
|
| ExclusionCriteria |
| Details |
1. Current or past diagnosis of major psychiatric or neurological disorders.
2. Use of anxiolytic, antidepressant, or mood-altering medications within the last 30 days prior to screening.
3. Known allergy or intolerance to any components of the NutriMind-2 or cocoa-based formulation.
4. Pregnancy, lactation, or any chronic medical condition (e.g., diabetes, thyroid disorders, cardiovascular disease) that may interfere with study outcomes or participant safety.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in Hamilton Anxiety Scale Score with at least 4 points over a 4 week period
2.Reduction in Social Media Disorder Scale scores with at least 4 points than before
|
1.Reduction in Hamilton Anxiety Scale Score and Social Media Disorder Scale scores within 30 days.
Follow up is at 15th and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in Perceived Stress Scale with at least 4 points scores over a month
2. Reduction in Fear of Missing Out (FOMO) scores with at least 4 points in a month
3. Better mood and less fatigue
4. Reduction in screen time
|
This outcome will be analyzed within 30 days
Follow up will be conduced at 15th and 30th day |
|
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Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
01/06/2026 |
| 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="0"
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
|
This is a Randomized Controlled Trial which evaluates efficacy of Nutrimind-2 which is a herbal neutraceutical and Cocoa based supplement in Social media-induced anxiety in young adults. A total no of 23 participants will be enrolled per group. Participants will be allocated randomly by computarized sampling. It is an open label study. A Group will receive Nutrimind-2 as an intervention and Group B will receive Cocoa supplement. Dose is 15 gm OD in both groups. Follow up is scheduled at 15th and 30th day. Outcomes will be analyzed by various scales like Hamilton Anxiety Rating Scale, Social Media Disorder Scale, Perceived Stress Scale, FOMO Scale. |