| CTRI Number |
CTRI/2022/07/044405 [Registered on: 27/07/2022] Trial Registered Prospectively |
| Last Modified On: |
27/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Assess The Role
Of a Homoeopathic Medicine
Guatteria Guameria and
Homoeopathic Medicines found out with totality In Cases With increased Total Cholesterol |
|
Scientific Title of Study
|
A Single Blind Randomised
Comparative Trial To Assess The Role
Of Predefined Homoeopathic Medicine
Guatteria Guameria & Individulaised
Homoeopathic Medicine In Cases With
Elevated Total Cholesterol |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
indira |
| Designation |
pg student |
| Affiliation |
mangilal nirban homoeopathic medical college and research institute bikaner |
| Address |
Mangilal Nirban Homoeopathic Medical College and Research Institute Bikaner Naino ka baas jaipur jodhpur bypass, room no 3 OPD
aipur jodhpur bypass ridmalsar bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
6375832327 |
| Fax |
|
| Email |
indira7658@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
indira |
| Designation |
pgr |
| Affiliation |
mangilal nirban homoeopathic medical college and research institute bikaner |
| Address |
Mangilal Nirban Homoeopathic Medical College and Research Institute Bikaner Naino ka baas jaipur jodhpur bypass, room no 3 OPD
Bikaner
RAJASTHAN
334001
India |
| Phone |
6375832327 |
| Fax |
|
| Email |
indira7658@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
indira |
| Designation |
PG student |
| Affiliation |
mangilal nirban homoeopathic medical college and research institute bikaner |
| Address |
Mangilal Nirban Homoeopathic Medical College and Research Institute Bikaner Naino ka baas jaipur jodhpur bypass, room no 3 OPD
Bikaner
RAJASTHAN
334001
India |
| Phone |
6375832327 |
| Fax |
|
| Email |
indira7658@gmail.com |
|
|
Source of Monetary or Material Support
|
| mangilal nirban homoeopathic medical college |
|
|
Primary Sponsor
|
| Name |
mangilal nirban homoepathic medical college and research institute |
| Address |
jaipur jodhpur bypass ridmalsar |
| 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 aijaz aziz sulemani |
mangilal nirban homoeopathic medical college |
Jaipur jodhpur bypass ridmalsar bikaner, Materia Medica department OPD number 3
Bikaner
RAJASTHAN |
9829049721
mnhmcbikaner@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE M N HOMOEPATHIC MEDICLAL COLLEGE AND R I BIKANER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E713||Disorders of fatty-acid metabolism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A- Guatteria guameria 1x. |
Doses and repetition- Guatteria guameria 1x.[9]
Manufacturer- Medicine will be obtained from a good manufacturer practice certified company.
Doses and repetition-According to patient’s susceptibility and homoeopathic principles.
Form- tablet form.
Route of administration- Oral
Dispensing- This will be done by the college dispensary. Assessment will be done for 12 months |
| Intervention |
Group B – Individualized homoeopathic medicines. |
Potency-Selection of potencies will be done according to patient’s susceptibilityand homoeopathic principles.
Doses and repetition-According to patient’s susceptibility and homoeopathic principles.
Manufacturer- Medicine will be obtained from a good manufacturer practice certified company.
Form- tablet form.
Route of administration- Oral
Dispensing- This will be done by the college dispensary.
Assessment will be done in 12 months
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Screening-Screening will be done on the basis of presenting complaints.
Cases of both sex will be included in the study irrespective of their caste, religion.
Patients giving concent for the study.
Patients cholesterol level is above 200 mg/dl
|
|
| ExclusionCriteria |
| Details |
Co-morbidites like liver disease, arthritis, tuberculosis.
Pregnant and lactating women.
patients suffering from other auto-immune diseases, HIV patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total cholesterol level |
Start of study and at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
0 |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
01/08/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prevalence study shows that
Review of population based studies in India shows increasing mean total
cholesterol levels. Recent studies have reported that high
cholesterol is present in 25–30% of urban and 15–20% rural subjects.
|
symptoms of Guatteria guameria palpitation and tachycardia
worse after eating. Congestion of liver,Acrid dyspepsia. Bilious yellow and green
vomiting,Lung infection on the right side. Painful cough with palpitations.
Urinary urea diminished.[4]
|
In an observational study on lipoproteinemia, wherein 322
patients were given individualized homoeopathic treatment treated out; of which
290 patients were improved. Inclusion criteria were TC more than 200 mg/100 ml.
Predisposing factors for dyslipidemia such as diabetes mellitus,
hypothyroidism, liver diseases, dietary factors, family history, and genetic
factors were also recorded during this study. Lycopodium clavatum, Calcarea
carbonica, Pulsatilla, Rhus tox, Sulphur, and Nux vomica were found useful in
treatment. Not only pathological parameters improved but also associated
symptoms of patients improvedThus this study is an attempt to compare the effectiveness of
Guatteria guameria
& individualized homoeopathic medicine cases of elevated
total cholesterol. |