| CTRI Number |
CTRI/2025/10/095776 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To understand the effectiveness of homoeopathic medicine Daphne indica for tobacco abuse. |
|
Scientific Title of Study
|
To understand the efficacy of Daphne indica for tobacco abuse, using Fagerstrom Test for Nicotine Dependence. |
| 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 Priyanka Hasani |
| Designation |
PG Scholar |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute |
| Address |
Room No 210 Department of Homeopathic Materia Medica, 1st floor Anand
Homeopathic Medical College And Research Institute Nr Sardar Baug, Bhalej Road, Anand
Anand
GUJARAT
388001
India |
| Phone |
6352026276 |
| Fax |
|
| Email |
hasanipriyankapmh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hetal Trivedi |
| Designation |
BHMS, MD (HOM), Principal of Anand homoeopathic Medical College and Research Institute |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute |
| Address |
Anand Homeopathic Medical College And Research Institute Nr Sardar Baug, Bhalej Road, Anand
Anand
GUJARAT
388001
India |
| Phone |
8200546255 |
| Fax |
|
| Email |
drhetaltrivedi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hetal Trivedi |
| Designation |
BHMS, MD (HOM), Principal of Anand homoeopathic Medical College and Research Institute |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute |
| Address |
Anand Homeopathic Medical College And Research Institute Nr Sardar Baug, Bhalej Road, Anand
GUJARAT
388001
India |
| Phone |
8200546255 |
| Fax |
|
| Email |
drhetaltrivedi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anand Homeopathic And General Hospital,Anand - 388001, Gujarat, India
|
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Hasani |
| Address |
133, Ranchhod park society, Ramnagar, Rander road, Surat-395005 |
| 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 Priyanka Hasani |
Anand Homeopathic And General Hospital |
Department Of Medicine
OPD No 1 Room No 1 Opp
Sardar Baug, Nr New Bus
Stand, Anand - 388001
Anand
GUJARAT |
06352026276
hasanipriyankapmh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ANAND HOMEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F17||Nicotine dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Daphne indica 30 |
Daphne indica 30, 4 globules would be administered orally. Repetition based on susceptibility and symptom severity. Follow up as the case demands. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients within the age group of 15-50 years, both male and female.
2.Current tobacco users: Individuals who currently use tobacco products in any form (e.g., chewing tobacco, cigarettes, smokeless tobacco, e-cigarettes, snuff) regularly.
3.Duration of tobacco use: Participants who have used tobacco for a minimum duration (e.g., at least 6 months or 1 year) to ensure a certain level of addiction or regular usage.
4.Motivation to quit: Individuals actively seeking help to quit or reduce tobacco use.
5.Willingness to participate: Participants must be willing to give informed consent and comply with the study protocol.
|
|
| ExclusionCriteria |
| Details |
1.Patients younger than 15 years or older than 50 years.
2.Non smokers: Participants who have never smoked or used any tobacco products.
3.Patients with serious health conditions that could confound the results or make participation unsafe (e.g., severe cardiovascular disease, lung cancer, or other terminal illnesses).
4.Pregnant or breastfeeding women: Tobacco use in pregnancy is a critical risk factor, so pregnant women may be excluded to focus on other aspects of tobacco abuse.
5. History of substance abuse: Participants with a history of drug or alcohol dependence (other than tobacco) may be excluded to isolate the effects of tobacco use.
6.Individuals not willing to participate: Those who are unwilling or unable to follow the study protocol, including adherence to follow-up visits.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in FTND score from baseline. |
Baseline, 3rd month, 6th month, 9th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in withdrawal symptoms such as anxiety, confusion, dizziness, irritability etc. |
Baseline, 3rd month, 6th month, 9th month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
As we know that tobacco use remains widespread in India owing to the social, cultural and psychological factors which leads to high prevalence of tobacco abuse among the citizens (especially the youth). This study is being conducted to test the efficacy of Daphne indica 30 for tobacco abuse. The main goal is to see if it reduces the craving effects for tobacco without any harmful side effects as in modern system of medicine, and also if it can manage the other withdrawal symptoms like anxiety, confusion, dizziness, irritability, loss of appetite etc. |