| CTRI Number |
CTRI/2025/11/097521 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Compare of Nux vomica 6c versus individualized homoeopathic medicines in treatment of people with functional dyspepsia |
|
Scientific Title of Study
|
In vitro antioxidant activity of Nux vomica 6C and open label randomised clinical trial to evaluate the effectiveness of Nux vomica 6C in comparison with individualised homoeopathic medicines in functional dyspepsia: an integrative 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 Mudalige Don Kusal Pradeep Gunawardana |
| Designation |
post graduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD no 18,Department of Homoeopathic Materia Medica,National Institute of Homoeopathy,Block GE,Sector 3,Salt Lake, kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
8697803860 |
| Fax |
|
| Email |
kusalpradeep91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kumaravel V |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD no 18,Department of Homoeopathic Materia Medica,National Institute of Homoeopathy,Block GE,Sector 3,Salt Lake, kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9748163274 |
| Fax |
|
| Email |
drkumaravelnih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr kumaravel V |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD no 18,Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3,Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9748163274 |
| Fax |
|
| Email |
drkumaravelnih@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata |
| 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 |
| Mudalige Don kusal Pradeep Gunawardana |
National institute of homoeopathy |
Department of materia medica. National institute of homoeopathy. Block GE Sector 3 Salt lake Kolkata
Kolkata
WEST BENGAL |
8697803860
kusalpradeep91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of the National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
individualized homoeopathic medicine |
dose and frequency will be selected as per the susceptibility of the case. follow up will be done monthly till 3 months from the baseline |
| Comparator Agent |
nux vomica 6c |
frequency of the medicine will be as per the susceptibility of the case. follow up will be done monthly till 3 months from the baseline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Age between 18 to 60 years Both sexes and all religions
2 Individuals who provide written informed consent
3 Females who are not pregnant or breastfeeding during the course of the study
4 Patients not currently taking any other treatment allopathic or homeopathic for dyspepsia
5 Patients who are otherwise clinically stable and fit to participate in the study
6 Individuals willing to adhere to follow-up visits and treatment protocol
7 Patients who are eligible to read Bengali English Hindi
8 Patients diagnosed clinically by DSSI score above 15
|
|
| ExclusionCriteria |
| Details |
1 Age below 18 and above 60
2 Pregnancy and Malignancy
3 Known case of cardiac and liver diseases
4 Patients on going treatment with corticosteroids immune suppressants
5 Patients suffering from any severe psychiatric illness
6 Patients not willing to give written consent
7 Patients diagnosed clinically by DSSI score below 15
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
evaluate the antioxidant activity of nux vomica 6c by using antioxidant assays and the response of the patients will be observed by changes in the DSSI score before and after intervention in assessed
|
Baseline and 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| : evaluate pre and post intervention changes of the quality of life of the patients by using SF-NDI |
baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
29/11/2025 |
| 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 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 research proposal aims to investigate the antioxidant properties of Nux vomica 6c and its clinical effectiveness in treating functional dyspepsia. Nux vomica is a common treatment for functional dyspepsia, particularly for symptoms related to a sedentary lifestyle. Although its therapeutic effectiveness has been established, the scientific understanding of its mechanism of action is limited. Few clinical studies have assessed the efficacy of Nux vomica in functional dyspepsia. Recent pharmacological research suggests that oxidative stress may play a significant role in dyspepsia, and antioxidant remedies may offer therapeutic benefits. However, the antioxidant properties of different Nux vomica potencies have not been thoroughly evaluated in vitro. There is a lack of integrative studies correlating the biochemical actions of Nux vomica with its clinical effects, limiting its validity in evidence-based frameworks. This knowledge gap highlights the need to compare preclinical (in vitro) results with clinical efficacy to validate the use of Nux vomica in functional dyspepsia from both scientific and homoeopathic perspectives. The study has two main components: in vitro assessment of Nux vomica 6c’s antioxidant potential using antioxidant assays and clinical comparison of Nux vomica 6c with individualized homoeopathic medicine in treating functional dyspepsia. A preclinical study followed by an open-label randomized clinical trial will be conducted. The sample size will be 128 patients (64 per group). The primary outcomes will be antioxidant activity of Nux vomica 6c b) Changes in Dyspepsia Symptom Severity Index (DSSI) scores. The secondary outcome will be quality of life changes measured by Short-Form Nepean Dyspepsia Index (SF-NDI). This study aimed to bridge the gap between the traditional use and scientific validity of Nux vomica in treating functional dyspepsia, addressing the lack of integrative studies correlating its biochemical actions with its clinical effects. |