| CTRI Number |
CTRI/2024/04/066492 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study effects of homoeopathic medicine & integrative medicine(homoeopathy and modern medicine) in patients with metabolic syndrome. |
|
Scientific Title of Study
|
A pilot study of metabolic syndrome metasynthesis of holistic medicine(homoeopathy) and integrative medicine. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankush Singha |
| Designation |
UG student |
| Affiliation |
Metropolitan Homeopathic Medical College and Hospital |
| Address |
OPD of department of practice of medicine of Metropolitan Homeopathic Medical College and Hospital
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
9433536167 |
| Fax |
|
| Email |
ankushsingha35@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankush Singha |
| Designation |
UG student |
| Affiliation |
Metropolitan Homeopathic Medical College and Hospital |
| Address |
OPD of department of practice of medicine of Metropolitan Homeopathic Medical College and Hospital
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
9433536167 |
| Fax |
|
| Email |
ankushsingha35@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Chandra Nath Das |
| Designation |
Principal |
| Affiliation |
Metropolitan Homeopathic Medical College and Hospital |
| Address |
Principal room at Metropolitan Homeopathic Medical College and Hospital
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
03325955326 |
| Fax |
|
| Email |
mhmch1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Metropolitan Homoeopathic Medical College and Hospital, Ramchandrapur, Sodepur, Kolkata - 700110 |
|
|
Primary Sponsor
|
| Name |
Metropolitan Homoeopathic Medical College and Hospital |
| Address |
Ramchandrapur, Sodepur, Kolkata -700110 |
| 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 Souraj Das |
Metropolitan Homoeopathic Medical College and Hospital |
OPD of department of practice of medicine in Metropolitan Homoeopathic Medical College and Hospital, Ramchandrapur, Sodepur, Kolkata-700110
North Twentyfour Parganas
WEST BENGAL |
9830247030
dr_sourajdas@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: E782||Mixed hyperlipidemia, (3) ICD-10 Condition: E660||Obesity due to excess calories, (4) ICD-10 Condition: E781||Pure hyperglyceridemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines, Integrative medicine (modern medicine and homoeopathic medicine. |
Homoeopathic medicines- Idividualized homoeopathic medicines for each patients for 6 months and doses according to totality of symptoms under the miasmatic background on the basis of homoeopathic philosophy.
Integrative medicine-mainly focusing on patients coming with ongoing treatment with modern medicines, where we will only administer homoeopathic medicine according to individualization. We will not be giving any allopathic medicines.
|
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
We will be considering patients who can satisfy any 3 out of these 5 criteria as per The National Cholesterol Education Program: Adult Treatment Panel III(NCEP: ATP III) later modified by American Heart Association(AHA) & National Heart, Lung and Blood Institute(NHLBI- 1)Abdominal obesity- ≥ 102 cm (40 inches) in males and ≥ 88 cm (35 inches) in females. 2)Hypertension- ≥130 mm Hg systolic blood pressure ; ≥85 mm Hg diastolic blood pressure or under antihypertensive drug treatment in a patient with a history of hypertension. 3)Hyperglycemia- ≥100 mg/dL or under drug treatment for elevated glucose. 4)Hypertriglyceridemia- ≥150 mg/dL (1.7mmol/ L) or under drug treatment for elevated triglycerides. 5)Low high density lipoprotien cholesterol levels- less than 40 mg/dL in males and less then 50 mg/dL in females or under drug treatment for reduced HDL-C levels
|
|
| ExclusionCriteria |
| Details |
1) Patients suffering from AIDS, cancer along with metabolic syndrome are excluded.
2)Pregnant & lactating women are excluded.
3)Patients with life threatening diagnosed heart and neurological disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Waist circumference- ≥ 102 cm (40 inches) in males and ≥88 cm (35 inches) in females.
Hypertension- ≥ 130/85 mm of hg
Blood sugar level- Fasting glucose test or HbA1C test or Oral Glucose Tolerance Test.
Triglyceride level- Triglycerides test (TGL) or Lipid profile test.
Low HDL-C level- High Density lipoprotein Cholesterol test(HDL-C test) or Lipid profile test.
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Waist circumference- ≥ 102 cm (40 inches) in males and ≥88 cm (35 inches) in females.
Hypertension- ≥ 130/85 mm of hg
Blood sugar level- Fasting glucose test or HbA1C test or Oral Glucose Tolerance Test.
Triglyceride level- Triglycerides test (TGL) or Lipid profile test.
High Density lipoprotein Cholesterol level- High Density lipoprotein Cholesterol test(HDL-C test) or Lipid profile test.
|
waist circumference and hypertension measured within every 2 weeks for 6 months.
Blood sugar level, Triglyceride level, High Density lipoprotein Cholesterol will be done twice, before administration of medicine and at the end of 6 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 |
|
Date of First Enrollment (India)
|
29/04/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ankushsingha35@gmail.com].
- For how long will this data be available start date provided 30-05-2024 and end date provided 30-06-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This pilot study is an non randomized , active controlled trial to test the effectiveness of homoeopathic medicines and integrative medicine on metabolic syndrome. In this pilot study, we aim to study a minimum of 50 patients within a frame of 6 months where they will be observed for 6 months with follow-up after every 2 weeks. Patients will be selected based upon inclusion criteria if they are presenting with any 3 out of 5 criteria. We planned on dividing patients into 2 groups, on one we will administer homoeopathic remedies based on the totality of symptoms under the miasmatic background on the basis of homoeopathic philosophy. For another group we will consider Integrative medicine mainly focusing on patients who are coming to our study site with ongoing treatment with modern medicines, where we will only administer homoeopathic medicine according to individualization. We will not be giving any allopathic medicines. General Management will be advised through- DASH diet / low GI Diet / MUFAs / n-6 VLC-PUFAs and exercises. Data collection and instrument used- (i) Waist circumference- To be measured with a measuring tape by placing tape in a horizontal plane around abdomen at the level of iliac crest. Before measuring ensure the tape is sung but does not compress the skin and is parallel to the floor. Measurement is made at the end of normal expiration in centimeters or inches.(ii) Blood pressure- To be measured with a sphygmomanometer & stethoscope.(iii) Lab tests such as(only one from each of these, as per patients needs will be done)-(a)Blood sugar level- Fasting glucose test/ HbA1C test/ Oral Glucose Tolerance Test. (b)Triglyceride level- Triglycerides test (TGL) / Lipid profile test. (c)Low HDL-C level- High Density lipoprotein Cholesterol test(HDL-C test) / Lipid profile test. Lab tests will be done twice, before administration of medicine and at the end of 6 months or when the patient gets better(may vary).Individualized homoeopathic medicines, potency of the medicines, doses, and form of administration on patients will be recorded. In case of integrative approach, a list of conventional group of medicines acting along homoeopathic medicines in patients will be recorded. The primary outcome measures will be Waist circumference- ≥ 102 cm (40 inches) in males and ≥88 cm (35 inches) in females; Hypertension- ≥ 130/85 mm of hg; Blood sugar level- Fasting glucose test or HbA1C test or Oral Glucose Tolerance Test; Triglyceride level- Triglycerides test (TGL) or Lipid profile test; Low HDL-C level- High Density lipoprotein Cholesterol test(HDL-C test) or Lipid profile test; at 6 months of time period and secondary outcome measures will be Waist circumference- ≥ 102 cm (40 inches) in males and ≥88 cm (35 inches) in females; Hypertension- ≥ 130/85 mm of hg; at every 2 weeks for 6 months & Blood sugar level- Fasting glucose test or HbA1C test or Oral Glucose Tolerance Test; Triglyceride level- Triglycerides test (TGL) or Lipid profile test; Low HDL-C level- High Density lipoprotein Cholesterol test(HDL-C test) or Lipid profile test; will be done twice before administration of homoeopathic medicine and after 6 months of administration of homoeopathic medicine. |