Exploring an individualised homoeopathic treatment (similimum) to modify anger and reduce blood pressure in patients with mild to moderate essential hypertension
| ISRCTN | ISRCTN26742330 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26742330 |
- Submission date
- 10/10/2022
- Registration date
- 18/10/2022
- Last edited
- 20/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Blood pressure is the force of blood against the arterial walls as the heart pumps blood through the body. Hypertension occurs when the force of the blood is higher than normal. Essential hypertension is high blood pressure that does not have a known cause. According to current research, anger, hostility, and aggression play a prominent role in the cause of high blood pressure. This research is about how anger affects blood pressure and how an individualised prescription of homoeopathic medicine affects the state of mind, especially anger and hostility.
The blood pressure readings may be temporarily higher or lower throughout the day. They change after exercise, after rest when one is in pain, and when happy or sad. Occasional high blood pressure readings do not necessarily mean the person has hypertension. A diagnosis of hypertension is not usually made unless the blood pressure readings are consistently high. The higher the blood pressure is, the harder the heart must work. A stronger force of blood can damage the arteries, blood vessels, and heart muscles. This can eventually cause reduced blood flow through the body, leading to atherosclerosis (hardening of the arteries from cholesterol build-up, which can lead to a heart attack), stroke, heart attack, heart failure, eye damage, and kidney damage. Most people do not have symptoms of essential hypertension and only discover that their blood pressure is high during a regular medical check-up. Hence hypertension is known as a silent killer. Essential hypertension can begin at any age. It most often occurs first during the middle-age years.
This study aims to understand how people respond physiologically to stress and the feelings of anger and irritation that arise with daily life and whether lifestyle changes, along with homoeopathic treatment, can reduce the occurrence of essential hypertension.
Who can participate?
Adults suffering from essential hypertension
What does the study involve?
Participants were asked to report their degree of anger in a questionnaire to better understand how people respond physiologically to stress and the feelings of anger and irritation they must deal with daily. Their answers were kept in the strictest confidence. We also ruled out heart and kidney problems by performing a blood test to check blood sugar and cholesterol levels, an electrocardiogram test (that records the electrical activity of the heart), a blood test and a urine test to check kidney function and an x-ray of the chest to check the heart and lungs. First, participants began with lifestyle changes to lower their blood pressure, by eating a low-sodium, low-fat diet that is rich in potassium and fibre, exercising at least 30 minutes a day, losing weight if they were overweight, quitting smoking, limiting daily alcohol intake to no more than one drink for a woman and two drinks for a man, and reducing their stress levels. When lifestyle changes did not lower the blood pressure levels enough, participants received antihypertensive treatment if it was stage II hypertension under the medical specialist's advice, along with homoeopathic treatment. Blood pressure and emotional state were monitored for six months.
What are the possible benefits and risks of participating?
Participants will benefit by being made aware of their unhealthy lifestyle and diet and developing insights about their anger. Their blood pressure will be better controlled, and they should foster better interpersonal relationships. Individualised homoeopathic medicine will also help with any associated illnesses (comorbidities) from which these participants may be suffering. There are no foreseeable risks as far as this study goes.
Where did the study run from?
Dr M L Dhawale Memorial Homoeopathic Institute (India)
When is the study starting and how long is it expected to run for?
March 2014 to July 2018
Who is funding the study?
Investigator initiated and funded (India)
Who is the main contact?
Dr Leena S Bagadia, leenabagadia@gmail.com (India)
Contact information
Principal Investigator
2, Palm Springs society
Mukteshwar Devalay Marg
Near Chandan cinema
Juhu
Mumbai
400049
India
 ORCID ID |
0000-0002-1823-963X |
|---|---|
| Phone | +91 9870098982 |
| leenabagadia@gmail.com |
Study information
| Study design | Randomized parallel-group placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 42571 PIS Hypertension research project.pdf |
| Scientific title | Exploring the role of the homoeopathic similimum in modifying anger: state, trait and expression in patients of mild to moderate essential hypertension. |
| Study acronym | MAHT |
| Study objectives | 1. Anger is an emotion that can be measured, and STAXI-2 can be successfully used for this purpose in our study population 2. There is a positive relationship between the components of anger and hypertension 3. Patients with a family history of hypertension are more prone to hyper-react to stressors and thereby more susceptible to hypertension 4. Essential hypertension can be improved by better anger coping mechanisms 5. There is a difference in the values of the different anger variables in rural and urban participants |
| Ethics approval(s) | Approved 06/12/2015, Ethics Committee of the Dr M L Dhawale Memorial Homoeopathic Institute (Palghar, Rural Homoeopathic Hospital, Palghar-Boisar Road, Opp. S.T. workshop, Palghar - 401404, India; +91 02525 256932/33; mldmhipg@gmail.com), ref: MLDMHI/M12- /2015 |
| Health condition(s) or problem(s) studied | Reduction of anger state, trait and expression in patients with essential hypertension |
| Intervention | This trial was a randomized, placebo-controlled, comparative, open-label study conducted at an urban and a rural charitable homoeopathic hospital and a plastics factory. The study protocol was conducted as per the latest revision of the Helsinki declaration. Statistical software was used to generate a random allocation sequence by an independent statistician before subject recruitment. After collecting an initial case history, participants were allocated to different groups at a 1:1 ratio. Intervention arm patients were given individualised homoeopathic treatment (the similimum) using homoeopathic medicines procured from Good Manufacturing Practices-certified pharmacies, along with their standard antihypertensive treatment. Individualised homoeopathic remedies will be prescribed depending on the totality of symptoms. It will be administered as medicine liquid, added as a drop onto sugar of milk powder and/or pills, and administered orally. Pills (which may or may not contain medicinal substance) will be given as 4 pills 3 times a day and powder 2-3 times a week or as per requirement. Therapy is continued for a 6-month study period and, if required, can be continued later. The comparator agent, the placebo is sugar of milk globules without adding homoeopathic medicine. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Individualised homeopathic medicines |
| Primary outcome measure | 1. Anger variables measured using the State-Trait Anger Expression Inventory-2 (STAXI-2) scale at the onset of the study and the end of six months study period: 1.1. State Anger (S-Ang) - the intensity of angry feelings at the time of completion 1.2. Trait anger (T-Ang) - a disposition to experience anger 1.3. Anger Expression-Out (Ax-O) - the expression of angry feelings out 1.4. Anger Expression-In (AX-I) - the suppression of angry feelings 1.5. Anger Control-Out (AC-O) - the prevention of anger expression toward other people or objects 1.6. Anger Control-In (AC-I) - the control of suppressed anger 1.7. Anger Expression Index (AX-index) - overall index of the frequency of anger expression, regardless of direction 2. Systolic and diastolic blood pressure measured using an Omron machine at every follow-up visit at 2-week intervals |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 15/03/2014 |
| Completion date | 31/07/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 172 |
| Key inclusion criteria | 1. Suffering from essential hypertension (pre-hypertensives: SBP 120-139 mm Hg, DBP 80-89 mm Hg, stage I hypertensives: SBP 140-159 mm Hg, DBP 90-99 mm Hg; stage II hypertensives: SBP more than or equal to 160 mm Hg, DBP more than or equal to 100 mm Hg 2. Patients on antihypertensive treatment 3. Aged 18-65 years 4. Patients whose history, examination and routine investigations revealed no evidence of apparent secondary cause |
| Key exclusion criteria | 1. Physical examination or routine investigations produced suspicion of a secondary cause for HT 2. Provisional or confirmatory diagnosis of secondary HT 3. Patients with uncontrolled Diabetes Mellitus or any uncontrolled endocrine disorders 4. Patients diagnosed with psychiatric disorders like schizophrenia or endogenous depression 5. Pregnant or breastfeeding mothers having HT |
| Date of first enrolment | 01/01/2016 |
| Date of final enrolment | 31/07/2018 |
Locations
Countries of recruitment
- India
Study participating centres
Mumbai
401404
India
Vile Parle west Mumbai (Suburban) Maharashtra
Mumbai
400056
India
Daman
396210
India
M. V. Road, Andheri East
Mumbai
400069
India
Sponsor information
University/education
Rural Homoeopathic Hospital
Palghar-Boisar Road
Opp. S.T. Workshop
Palghar
Mumbai
401404
India
| Phone | +91 02525-256932/33 |
|---|---|
| mldmhipg@gmail.com | |
| Website | https://mldmhi.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 15/11/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available upon request from the principal investigator Dr Leena S Bagadia, leenabagadia@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 18/10/2022 | No | Yes | ||
| Participant information sheet | 18/10/2022 | No | Yes | ||
| Protocol file | 18/10/2022 | No | No | ||
| Statistical Analysis Plan | 18/10/2022 | No | No | ||
| Abstract results | 01/06/2022 | 20/01/2023 | No | No |
Additional files
Editorial Notes
20/01/2023: Abstract added.
18/10/2022: Trial's existence confirmed by the Ethics Committee of the Dr M L Dhawale Memorial Homoeopathic Institute.
