| CTRI Number |
CTRI/2024/12/077955 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A prospective clinical trial to assess the role of Homoeopathic medicine Terminalia arjuna and Guatteria Gaumeri in reducing lipid level in body
|
|
Scientific Title of Study
|
Comparative evaluation of the effectiveness of Terminalia arjuna and Guatteria gaumeri in the management of dyslipidemia: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nipun Singh Dabi |
| Designation |
Assistant Professor |
| Affiliation |
Madhav Homoeopathic Medical College and Hospital |
| Address |
Room No. - 04 (A), Medicine OPD, Madhav Homoeopathic Medical College and Hospital, Madhav University, Aburoad, Sirohi Rajasthan
Sirohi
RAJASTHAN
307026
India |
| Phone |
9602456007 |
| Fax |
|
| Email |
nipunsinghdabi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jagdish Thebar |
| Designation |
Professor |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
Room no. 901, Practice of medicine & essentials of pharmacology, Department of Practice of Medicine, Swasthya Kalyan Homoeopathic Medical College and Research Centre
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829391362 |
| Fax |
|
| Email |
thebarjagdish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nipun Singh Dabi |
| Designation |
Assistant Professor |
| Affiliation |
Madhav Homoeopathic Medical College and Hospital |
| Address |
Room No. - 04 (A), Medicine OPD, Madhav Homoeopathic Medical College and Hospital, Madhav University, Aburoad, Sirohi Rajasthan
Sirohi
RAJASTHAN
307026
India |
| Phone |
9602456007 |
| Fax |
|
| Email |
nipunsinghdabi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madhav Homoeopathic Medical College and Hospital, Madhav University, Madhav Hills" Opp. Banas River Bridge Toll N.H.-27, P.O. - Bharja, Abu Road, Pindwara, Rajasthan 307026 |
|
|
Primary Sponsor
|
| Name |
Dr. Nipun Singh Dabi |
| Address |
Dabi Bhavan, Nayavas No.2,Sirohi, Rajasthan-307001 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Nipun Singh Dabi |
Madhav Homoeopathic Medical College and Hospital |
Room No. - 04 (A), Medicine OPD, Madhav Homoeopathic Medical College and Hospital, Madhav University, Aburoad, Sirohi Rajasthan
Sirohi
RAJASTHAN |
9602456007
nipunsinghdabi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swasthya Kalyan Homoeopathic Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E780||Pure hypercholesterolemia, (2) ICD-10 Condition: E781||Pure hyperglyceridemia, (3) ICD-10 Condition: E782||Mixed hyperlipidemia, (4) ICD-10 Condition: E783||Hyperchylomicronemia, (5) ICD-10 Condition: E784||Other hyperlipidemia, (6) ICD-10 Condition: E786||Lipoprotein deficiency, (7) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Guatteria gaumeri |
4 gobules in size 30 for three times a day for three months |
| Intervention |
Terminalia arjuna |
4 gobules in size 30 for three times a day for three months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of Dyslipidemia: Participants must have a confirmed diagnosis of dyslipidemia,
characterized by abnormal lipid levels.
2. Age Group: Adults aged 18-65 years of both sexes.
4. Willingness to Participate: Participants must be willing to follow the study protocol, attend
follow-up visits, and adhere to the prescribed treatment (either Terminalia Arjuna or Guatteria
Gaumeri).
5. Signed Informed Consent |
|
| ExclusionCriteria |
| Details |
1. Severe Cardiovascular Conditions with a history of recent cardiovascular events within the last
six months.
2. Existing Treatment for Dyslipidemia: Patients who are currently on any other lipid-lowering
medications (e.g., statins, fibrates) and unwilling to discontinue or who cannot discontinue for medical reasons.
3. Chronic Liver or Kidney Disease: Individuals with severe liver disease or renal insufficiency,
as these conditions could interfere with lipid metabolism or the safety of the remedies.
4. Pregnancy or Lactation.
5. Use of Alternative or Complementary Medicines: Patients using other herbal or alternative
treatments that may interfere with lipid levels.
6. Severe Mental Health Conditions: Individuals with unmanaged psychiatric conditions that may
impact adherence to the study protocol or affect their ability to give informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent reduction in lipid levels from baselineline score after intervention |
3 months after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Weight loss, |
3 months after intervention |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
24/12/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Dyslipidemia encompasses elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-c), TGs, or low HDL-c. It is a well-established risk factor for cardiovascular disease (CVD). Elevated LDL-c is a major contributor to atherosclerosis, and low HDL-c is also linked to CVD.1 These conditions are prevalent and often linked to genetic predispositions, environmental factors (such as diet, lifestyle, and medical conditions), and can significantly increase the risk of atherosclerotic cardiovascular disease (ASCVD). Elevated triglycerides can also lead to acute pancreatitis, necessitating intervention Dyslipidemia is a global public health problem that affects millions of people and increases the risk of cardiovascular disease, the leading cause of death worldwide. The epidemiology of dyslipidemia varies by region, age, sex, and ethnicity and is influenced by genetic and environmental factors. Despite the widespread use of statins and other medications for treating dyslipidemia, there is growing interest in exploring alternative therapies. Homeopathic remedies are being considered for their potential to lower elevated lipid levels without the adverse side effects often associated with conventional treatments, which are typically lifelong and pose health risks to patients. Given that dyslipidemia is a key factor in conditions like ASCVD, insulin resistance, type 2 diabetes, NAFLD, PCOD, and metabolic syndrome, safer, holistic approaches to treatment are needed.6 Homeopathy, which focuses on individualized patient care, may offer such an approach. However, the specific roles of remedies like Terminalia arjuna and Guatteria gaumeri in dyslipidemia management have not been adequately studied, making this an important area for further research in homeopathy.
Research question- Is there any significant difference between cases of dyslipidemia receiving predefined medicines Terminalia arjuna and cases receiving Guatteria gaumeri? Hypothesis: Null Hypothesis (H0) – There is no significant difference in the lipid-lowering effects between Terminalia Arjuna and Guatteria Gaumeri in patients with dyslipidemia Alternate hypothesis (H1) – There is significant difference in the lipid-lowering effects between Terminalia Arjuna and Guatteria Gaumeri in patients with dyslipidemia Alternate hypothesis (H2) – Terminalia arjuna is more effective in cases of dyslipidemia than Guatteria Gaumeri. Alternate hypothesis (H3) – Guatteria Gaumeri is more effective in cases of dyslipidemia than Terminalia arjuna. Alternate hypothesis (H4) – Terminalia arjuna is not effective in cases of dyslipidemia. Alternate hypothesis (H5) – Guatteria Gaumeri is not effective in cases of dyslipidemia.
AIM & OBJECTIVE Aim To assess and compare the effectiveness of Terminalia Arjuna and Guatteria Gaumeri in managing lipid profiles among patients with dyslipidemia.
Objective To evaluate and compare the effects of Terminalia Arjuna and Guatteria Gaumeri on lowering LDL cholesterol, total cholesterol, and triglycerides in patients diagnosed with dyslipidemia. To assess the impact of Terminalia Arjuna and Guatteria Gaumeri on increasing HDL cholesterol levels. To determine the overall improvement in lipid profiles between the two treatment groups. |