| CTRI Number |
CTRI/2024/05/067291 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Study of homoeopathic medicine in patients with Essential high blood pressure and anger management |
|
Scientific Title of Study
|
Effectiveness of Homeopathic Medicines in Essential Hypertension with Anger Management - A Non controlled Experimental Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish A Bhagat |
| Designation |
Professor |
| Affiliation |
SJPESs HMC and Hospital Kolhapur |
| Address |
Room no 1 ,OPD and Department of Practice of medicine,SJPESs Homoeopathic Medical College and Hospital ,Tararani Chauk Kolhapur
SJPESs Homoeopathic Medical College and Hospital ,Tararani Chauk Kolhapur
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9822302313 |
| Fax |
02312668810 |
| Email |
ashu1411@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata R Kamire |
| Designation |
Professor |
| Affiliation |
SJPESs HMC Kolhapur |
| Address |
Room no 1 , OPD and Department of Practice of medicine,SJPESs Homoeopathic Medical College and Hospital ,Tararani Chauk Kolhapur
SJPESs Homoeopathic Medical College and Hospital ,Tararani Chauk Kolhapur
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9823195866 |
| Fax |
02312652480 |
| Email |
phdsynopsis40@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish A Bhagat |
| Designation |
Professor |
| Affiliation |
SJPESs HMC , Kolhapur |
| Address |
Room no 1 ,OPD and Department of Practice of medicine,SJPESs Homoeopathic Medical College and Hospital ,Tararani Chauk Kolhapur
SJPESs Homoeopathic Medical College and Hospital ,Tararani Chauk Kolhapur
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9822302313 |
| Fax |
02312652480 |
| Email |
ashu1411@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SJPESs Homoeopathic Medical College and Hospital,Tararani chouk At Post-Kolhapur Dist- Kolhapur,State- Maharashtra,Country-India Pin-416003 |
|
|
Primary Sponsor
|
| Name |
Dr Ashish A Bhagat |
| Address |
SJPESs Homoeopathic Medical College and HOspital,Tararani chouk At Post-Kolhapur Dist- Kolhapur,State- Maharashtra,Country-India pin-416003 |
| Type of Sponsor |
Other [SELF SPONSORED RESEARCH] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR SUJATA R KAMIRE |
SJPESs HMC KOLHAPUR |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish A Bhagat |
SJPESs Homoeopathic medical college and Hospital |
Room no 1,OPD of Department of Practice of Medicine
Kolhapur
MAHARASHTRA |
09822302313
02312652480
ashu1411@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of SJPESs Homoeopathic Medical College,KOLHAPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines in Essential Hypertension with Anger Management |
Dose is selected as per the patients susceptibility, Frequency of followups is for 15-20 days, Route of administration is oral route and Duration of therapy is 6 months till the date of improvement . Follow ups at the intervals of 15-20 days. Total duration of study is 18 months |
| Comparator Agent |
Not Applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients 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;
b. Patients on antihypertensive treatment
c. Patients of age group 18 to 60 yrs.
d. Patients with essential hypertension with
no target organ affected
e. All sexes
f. Any socio- economic background
|
|
| ExclusionCriteria |
| Details |
a. Provisional or confirmatory diagnosis of
secondary HT.
b. Gestational hypertension
c. Malignant Hypertension
d. Patients of severe complications of
essential hypertension
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study Anger Assessment Ratings on STAXI-2 should reduce significantly at the end of the study when compared with the pre-test scores
2. To study Subjective Distress
3.To study Objective Parameters:
- Systolic & Diastolic Blood Pressure
|
1. Duration of study: 18 months.
2. Duration of each case: Cases will be managed upto the date of
improvement or observed for a periodof minimum 6 months.
3. Duration of follow up of each case:The follow ups will be taken
at the interval of 15-20 days.
4. whole result of outcome will be explained at the end of 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The outcome measures will be changes in the systolic and / or diastolic blood pressure at a timeline of six months. 2.The effect size was considered as the lowering of systolic and diastolic BP by a minimum of 15 mm and 6 mm of Hg, respectively. Thus, cases where this lowering in SBP and DBP was observed will be scribed as ‘improved’ and the rest ‘not improved’.
3.The study end-point will be lowering of BP following intervention. The primary safety end-point will be any adverse event during the study in any of the groups. The stopping guidelines will be, a marked deterioration of health condition and / or constant increase in BP among subjects in either group |
6 months |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
30/05/2024 |
| 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="1"
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 (Others) - Blood pressure LEVELS BEFORE AND AFTERTREATMENTWILL BE SHARED TO EXPLAIN THE IMPROVED AND NOT IMPROVED RESULTS.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
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 (Others) - SOFT COPY OF DATA WILL BE MADE AVAILABLE ON EMAIL WHOSOEVER REQUIRES IT.
- For how long will this data be available start date provided 07-05-2024 and end date provided 30-10-2025?
Response (Others) - THE DATA WILL BE MADE AVAILABLE TIME TO TIME AS PER ABOVE REQUIREMENT
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Hypertension is one such disease which is gaining global attention due to its prevalence morbidity and complication. It is called as silent killer because it rarely provides symptoms before it damages the heart brain or kidney.1Approximately 7.6 million death (13 - 15 % of total ) and 92 million disability adjusted life years worldwide were attributed to high blood pressure.According to API textbook of medicine the prevalence of hypertension increases with growing age and it is estimated that starting from around 15 % to 20 % in early age it increases to 75% to 80% in individuals above 70 years of age.Essential hypertension, also known as primary or idiopathic hypertension, is the presence of high blood pressure not explainable by secondary causes, representing 95% of all cases of high blood pressure. Aim and Objectives: Primary Objective- To study the efficacy of homoeopathic similimum in patients with mild to moderate EHT in modifying the underlying anger trait.Other objective 1- Identifying the anger trait and expressions with the help of State – Trait Anger Expression Inventory – 2 (STAXI- 2) in patients having EHT.Correlating the anger trait with systolic and diastolic blood pressure levels.Other Objective 2- Evolving the group of remedies commonly indicated in managing EHT where anger is a significant aetiological factor.Study Design:Single arm Non-Controlled Experimental studyStudy setting:a.cases of essential hypertension will be collected from college and Private OPDb.Screening and enrollment followed by intervention and follow-up for six months Study Population and Sampling:Clinically diagnosed cases of essential hypertension will be collected from above setting Sample size Calculations – We calculate the sample size as 82 respondents as per inclusive criteria Sampling techniques- simple random sampling technique STUDY DURATION : 4 years Study Area : Department of Practice of MedicineData Collection Methods and Instruments:Inclusion criteria a.Patients 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 ;b.Patients on antihypertensive treatment.c.Patients of age group 18 to 60 yrs.d.Patients with essential hypertension with no target organ affected.e.All sexesf.Any socio- economic background Exclusion Criteria:Provisional or confirmatory diagnosis of secondary HT,Gestational hypertension,Malignant Hypertension,Patients of severe complications of essential hypertension Subject withdrawal criteria:Patients who develop complications during course of treatment ,Patients not willing to continue further for homoeopathic treatment during ongoing research study despite of recovery,Patients who fail to give regular follow-up,Patients diagnosed with other disease during the course of treatment requiring in the case.Data collection tool:1.Complete homoeopathic case taking Performa to form totality.2.STAXI-2 (Spielberg et al., 1988) based questionnaire will be used for anger assessment. The Hindi version of STAXI-2, translated and validated by Saini will be used for patients not understanding English. Method of Measurement of each case:Screening for essential hypertension in OPDs.,Patient enrolment in study was according to Inclusion and Exclusion Criteria, Informed Consent, Appropriate use of software for Repertorization of case.Anger Assessment Scale will be applied to both study groups at the beginning and at the end of study period.,Along with case-taking, patients will be advised for sodium (salt) restricted (DASH) diet and exercises, and will be also made aware of harmful effects of anger.,Routine investigations like CBC, BSF, BSPP, Serum Creatinine, lipid profile, Serum Uric acid, urine routine, x-ray chest, ECG,USG abdomen will be and duly recorded in order to rule out secondary causes of hypertension.,.Data analysis methods -:The data analysis includes:Estimation of STAXI 2 (Anger Assessment Scale),Comparison of Anger Assessment ratings between two groups and within each group (state, trait and expressions),Correlation of Anger Assessment ratings with Systolic and Diastolic Blood Pressure.Data would be statistically analyzed. Appropriate charts, diagrams. Tables will be used as statistical techniques. Outcome Assessment:Anger Assessment Ratings on STAXI-2 should reduce significantly at the end of the study when compared with the pre-test scores, Subjective Distress, Objective Parameters:, Systolic & Diastolic Blood Pressure, The outcome measures will be changes in the systolic and / or diastolic blood pressure at a timeline of six months. STATISTICAL METHODS: Comparison will be done at a difference of 5% of significance level.Paired ‘t’ will be used to assess the comparison before and after the treatment in same patient and unpaired ‘t’ test for group comparisons.Chi – Square test will be used to determine the association between the effect of homoeopathic medication on anger and blood pressure.
|