| CTRI Number |
CTRI/2025/08/092907 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find out the effectiveness of homoeopathic medicines from nightshade family on patient’s mind and understanding its action. |
|
Scientific Title of Study
|
Psychoactive effects of the Solanaceae family in homoeopathy- A pharmacological and clinical 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 |
Damini Soni |
| Designation |
PG Scholar MD Part II |
| Affiliation |
S.S. Agrawal homoeopathic medical college and hospital navsari gujarat |
| Address |
PG division, 5th floor, Department of Homoeopathic Pharmacy, near devina park society Gandevi road Navsari Gujarat India
Navsari
GUJARAT
396445
India |
| Phone |
8160994294 |
| Fax |
|
| Email |
damini305@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Damini Soni |
| Designation |
PG Scholar MD Part II |
| Affiliation |
S.S. Agrawal homoeopathic medical college and hospital navsari gujarat |
| Address |
PG Division, 5th floor, Department of Homoeopathic Pharmacy, near devina park society, Gandevi road, Navsari, Gujarat.
Navsari
GUJARAT
396445
India |
| Phone |
8160994294 |
| Fax |
|
| Email |
damini305@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Chandra Shekhar Yadav |
| Designation |
Professor of Homoeopathic Pharmacy |
| Affiliation |
S.S. Agrawal homoeopathic medical college and hospital navsari gujarat |
| Address |
PG Division, 5th floor, Department of Homoeopathic Pharmacy, near devina park society, Gandevi road, Navsari, Gujarat.
Navsari
GUJARAT
396445
India |
| Phone |
9302218005 |
| Fax |
|
| Email |
drshekharyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.S. Agrawal Homoeopathic Medical college and hospital, near devina park society, Gandevi road, Navsari, Gujarat, India. Pin code 396445. |
|
|
Primary Sponsor
|
| Name |
SS Agrawal Homoeopathic Medical college and hospital |
| Address |
near devina park society, Gandevi road, Navsari, Gujarat, India. |
| Type of Sponsor |
Private 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 Damini Soni |
S.S. Agrawal Homoeopathic Medical college and hospital Navsari |
Medicine OPD, Ground floor, near devina park society, Gandevi road, Navsari, Gujarat.
Navsari
GUJARAT |
8160994294
damini305@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines-Belladonna,Hyosyamus,Stramonium,Tabacum |
Four homoeopathic medicines from solanaceae family Belladonna, Hyoscyamus niger, Stramonium, Tabacum will be prescribed based on the symptoms, individual totality and susceptibility of the patient and the potency will be selected accordingly. The administration of medicine will be by oral route and the follow ups will be taken. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The diagnostic criteria are mainly based on the clinical presentation. Addiction, Alcoholics, smokers, tobacco chewers, cannabis users. Anxiety, Depression, Mania, Mood Disorders, Recurrent Panic Attacks (panic disorder), Insomnia, Post Traumatic Stress Disorder. |
|
| ExclusionCriteria |
| Details |
Subjects of age below 15 years and above 60 years will be excluded.
Cases of dementia, Parkinson’s disease, Organic delusional disorder, Induced delusional disorder and other severe psychiatric comorbidity.
Patients under the treatment of higher psychotropic drugs.
Subjects who are pregnant or lactating
Severe systemic illness using conventional treatment and neurological surgical intervention.
Immuno-compromised conditions like HIV, Tuberculosis etc
Severe Drug addicts under the influence of cocaine, Morphine, hallucinogens, Lysergic acid derivatives and other drugs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluating the effectiveness of homoeopathic remedies derived from the Solanaceae plants in treating conditions associated with their psychoactive effects. |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exploring the mechanism of action through which Solanaceae plants exert their psychoactive effects in homeopathic preparations & study the pharmacological action. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
23/08/2025 |
| 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 single centre randomised clinical study to understand the psychoactive effects and pharmacological properties of the homoeopathic medicines belladonna stramonium hyosyamus niger tabacum which belong to solanaceae family through clinical study in assessing whether these drugs produce desired therapeutic effects. The study will be for the duration of 12 months and will be assessed using brief psychiatric rating scale BPRS to measure the symptom severity before and after the treatment. Case taking will be done and based on the individual totality of the symptoms and susceptibility medicine will be selected and administered in the desired potency. |