| CTRI Number |
CTRI/2018/04/013447 [Registered on: 24/04/2018] Trial Registered Prospectively |
| Last Modified On: |
24/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homeopathic treatment of gastric troubles |
|
Scientific Title of Study
|
Evaluating the role of additive mother tinctures to individualized homeopathic treatment of functional dyspepsia: an open randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abijit Chattopadhyay |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD room no. 12 and 13, Dept. of Homoeopathic Materia Medica;
Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
7003547446 |
| Fax |
|
| Email |
drac.nih@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anaitullah Ahmad Mir |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD room no. 12 and 13, Dept. of Homoeopathic Materia Medica;
Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9419039499 |
| Fax |
|
| Email |
civildefence12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anaitullah Ahmad Mir |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD room no. 12 and 13, Dept. of Homoeopathic Materia Medica;
Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9419039499 |
| Fax |
|
| Email |
civildefence12@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India; Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy Ministry of AYUSH Govt of India |
| Address |
Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal |
| 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 |
| Abhijit Chattopadhyay |
National Institute of Homoeopathy, Govt. of India |
OPD room no. 12 and
13, Dept. of
Homoeopathic Materia
Medica; Block GE,
Sector III, Salt Lake,
Kolkata 700106
Kolkata
WEST BENGAL |
7003547446
drac.nih@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Indicated homeopathic
medicines in centesimal or fifty
millesimal potencies |
Indicated homeopathic
medicines in centesimal or fifty millesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of a single drop of the indicated medicine (preserved in 90% v/v
ethanol) in 5 ml of distilled
water; dosage and repetition
depending upon the individual
requirement of the cases. In 50 millesimal scale, a single
medicated cane sugar globules
of poppy seed size (no. 10)
shall be dissolved in 90 ml
distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken
after 10 uniformly forceful
downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup.
Medicines are to be taken orally on clean tongue with empty stomach. Duration of therapy: 4 months |
| Intervention |
Indicated homeopathic
medicines in centesimal or fifty millesimal potencies plus one of the six following mother tinctures as indicated: Robinia pseudacacia, Iris versicolor, Hydrastis canadensis, Abies canadensis, Abies nigra, and Carica papaya |
Indicated homeopathic
medicines in centesimal or fifty millesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of a single drop of the indicated
medicine (preserved in 90% v/v
ethanol) in 5 ml of distilled
water; dosage and repetition
depending upon the individual
requirement of the cases. In 50 millesimal scale, a single
medicated cane sugar globules
of poppy seed size (no. 10)
shall be dissolved in 90 ml
distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken
after 10 uniformly forceful
downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard
rest of the liquid from the cup. Mother tinctures will be
administered in individualized
dosage (10-20 drops once to thrice daily in half cup of
normal water). The following
mother tinctures will be used as per indications: 1. Robinia pseudacacia 2. Iris versicolor 3. Hydrastis canadensis 4. Abies canadensis, 5. Abies nigra, and 6. Carica papaya. Medicines are to be taken orally on clean tongue with empty stomach. Duration of therapy: 4 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-65 years
2. Both sexes
3. Functional dyspepsia as per the Rome III criteria: One or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis –
a) Bothersome postprandial fullness
b) Early satiation
c) Epigastric pain
d) Epigastric burning
And, no evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms.
4. Patients already undergoing regular therapy for dyspeptic ailments, provided the medications are stopped completely at least 2 weeks prior study entry
5. Providing written informed consent
6. Literate patients; ability to read English and/or Bengali |
|
| ExclusionCriteria |
| Details |
1. Recent significant GI surgery within last 6 months
2. Patients who are too sick for consultation
3. Unable to read patient information sheet
4. Unwilling to take part and not giving consent to join the study
5. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life
6. Pregnancy and lactation
7. Substance abuse and/or dependence
8. Self-reported immune-compromised state, and
9. Undergoing homeopathic treatment for any chronic disease within last 6 months |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Translated Bengali version of Leeds dyspepsia questionnaire |
Baseline, after 2 months and after 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of use of standard conventional drugs for functional dyspepsia |
4 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/04/2018 |
| 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) |
Open to Recruitment |
|
Publication Details
|
None yet; to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Functional dyspepsia is a clinical syndrome characterized by chronic or recurrent upper abdominal pain or discomfort having no identifiable cause. Symptoms should be present for a minimum of 3 months; however, symptoms for greater than 6 months are typical. This disorder is not a mono-symptomatic entity; several predominant symptoms may be present, including epigastric pain (22%), abdominal fullness (24%), bloating (15%), vomiting (3%), belching (8%), early satiety (12%), nausea (10%), and heartburn (6%). Individuals with functional dyspepsia suffer significant morbidity and expend significant resources through both direct and indirect costs. Despite periods of remission, patients will usually have continued intermittent symptoms long-term, with approximately 50% consulting a health care provider for their symptoms at some time in their life. Medical treatment options for functional dyspepsia remain limited. In addition, up to 60% of patients respond to placebo, which further limits tests of pharmaceutical effectiveness in this patient population. Thus controversies regarding efficacy of the mainstay pharmacological agent and inadequacy of outcomes, people frequently refer to CAM therapies and homeopathy, but published researches on such treatment is sparse. A literature search found few evidences relating to the treatment of dyspepsia with homeopathy. Different plant extracts in the form of mother tinctures are frequently prescribed as additive to individualized remedies in homeopathy to treat dyspepsia; however, those have neither been systematically documented, nor were their efficacy and indications verified till date. In this open, randomized, prospective, parallel arm, clinical trial, 128 patients suffering from functional dyspepsia will be randomized to either individualized homeopathy plus mother tincture arm (verum; IH + MT; n=64) or individualized homeopathy alone (control; IH; n=64). Outcomes will be measured in terms of Leeds dyspepsia questionnaire, measured at baseline, after 2 months and 4 months, and frequency of add-on standard conventional drugs for functional dyspepsia during study period of 4 months. Comparative analysis will be carried out in the end to detect group differences, if any. Results will be published in scientific journals. |