| CTRI Number |
CTRI/2023/07/055898 [Registered on: 31/07/2023] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Hypertriglyceridemia with Fucus Vesiculosus vs Atorvastatin |
|
Scientific Title of Study
|
A randomized controlled comparative pilot study to evaluate the efficacy of Fucus vesiculosus mother tincture in the treatment of Hypertriglyceridemia versus conventional Atorvastatin |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hima Bindu Ponnam |
| Designation |
Research Officer (H), Scientist III |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Regional Research Institute (Homoeopathy), OUB-32, Vikrampuri, Habsiguda, Street No.4, Hyderabad
Email: drdewdrop@gmail.com
Hyderabad
TELANGANA
500007
India |
| Phone |
09490009899 |
| Fax |
|
| Email |
himabindu@ccrhindia.nic.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hima Bindu Ponnam |
| Designation |
Research Officer (H), Scientist III |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Regional Research Institute (Homoeopathy), OUB-32, Vikrampuri, Habsiguda, Street No.4, Hyderabad
Email: drdewdrop@gmail.com
Hyderabad
TELANGANA
500007
India |
| Phone |
09490009899 |
| Fax |
|
| Email |
himabindu@ccrhindia.nic.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hima Bindu Ponnam |
| Designation |
Research Officer (H), Scientist III |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Regional Research Institute (Homoeopathy), OUB-32, Vikrampuri, Habsiguda, Street No.4, Hyderabad
Email: drdewdrop@gmail.com
Hyderabad
TELANGANA
500007
India |
| Phone |
09490009899 |
| Fax |
|
| Email |
himabindu@ccrhindia.nic.in |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65 Institutional area Opp D block Janakpuri
New Delhi 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65 Institutional area Opp D block Janakpuri
New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Hima Bindu Ponnam |
Regional Research Institute (Homoeopathy) |
OPD-1, Room No.1, OUB 32, Vikrampuri, Habsiguda,
Street No. 4
Hyderabad
TELANGANA |
9490009899
drdewdrop@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Regional research Institute (Homoeopathy), Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E781||Pure hyperglyceridemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atorvastatin |
Atorvastatin 10 – 40 mg daily dose for 12 weeks (dosage to be followed as prescribed by the allopathic physician) |
| Intervention |
Fucus Vesiculosus Mother Tincture |
Each dose of the medicine shall consist of 15 drops (0.75m1) mother tincture T.I.D. in half a cup of water for 12 weeks. The dosage has been taken following the safety limits opined in the British Herbal Compendium 1992 and in reference to Homoeopathic Materia Medica. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Men and women aged 20-65 years.
2.Known case of Hypothyroid, Type 2 Diabetics and Hypertension with control under medication.
3.Other systemic disorders under control with treatment.
4.Women surgically sterile, post-menopausal, are agreed to practice adequate contraception.
5.Written Informed consent from the patient.
6.Cases falling under Mild and Moderate [20]category of Serum Triglyceride levels as per the classification of Endocrine Society 2010
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy, breastfeeding.
2.Cases with other uncontrolled systemic diseases like Hypothyroidism, Cardiovascular, Endocrinal diseases or systemic infections.
3.Low levels of Vitamin D.
4.Previous history of cardiovascular disease and cerebra stroke.
5.Suffering from known liver disorders.
6.Cases falling under Severe category of Serum Triglycerides levels as per the classification of Endocrine Society 2010.
|
|
|
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 |
| Improvement assessment of the changes in Lipid profile at baseline, 8th week & 12th week |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
BMI
FFQ
QoL by SF 36 |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/08/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study shall be a randomized comparative study in which patients will be recruited from the General OPD of the Institute/Unit.
The principal analyses of primary and secondary outcomes will be carried out by using the "per protocol" approach. All statistical tests will be two-sided. All the data shall be assessed for normal distribution. All analyses will be conducted using IBM SPSS version 20.0. Kolmogorov-Smirnov tests shall be used to analyze the normality of the data distribution.Comparison of the baseline characteristics among the two treatment groups will be done using parametric and non-parametric tests like independent t test, Wilcoxon rank sum test. The data should be presented n (%), Mean ±SD or median(IQR), odds ratio, relative risk. The result will be presented with 95% confidence intervals (Cl) and the p value<0.05 will be considered as the statistically significant. For the primary outcome and each of the secondary outcomes, per protocol analysis will be done. |