UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051745 |
|---|---|
| Receipt number | R000059058 |
| Scientific Title | TO COMPARE THE EFFECTIVENESS OF CENTESIMAL VERSUS FIFTY-MILLESIMAL SCALE IN THE MANAGEMENT OF TYPE-2 DIABETES MELLITUS |
| Date of disclosure of the study information | 2023/07/29 |
| Last modified on | 2024/02/10 23:27:14 |
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Basic information
Public title
TO COMPARE THE EFFECTIVENESS OF CENTESIMAL VERSUS FIFTY-MILLESIMAL SCALE IN THE MANAGEMENT OF TYPE-2 DIABETES MELLITUS
Acronym
TO COMPARE THE EFFECTIVENESS OF CENTESIMAL VERSUS FIFTY-MILLESIMAL SCALE IN THE MANAGEMENT OF TYPE-2 DIABETES MELLITUS
Scientific Title
TO COMPARE THE EFFECTIVENESS OF CENTESIMAL VERSUS FIFTY-MILLESIMAL SCALE IN THE MANAGEMENT OF TYPE-2 DIABETES MELLITUS
Scientific Title:Acronym
TO COMPARE THE EFFECTIVENESS OF CENTESIMAL VERSUS FIFTY-MILLESIMAL SCALE IN THE MANAGEMENT OF TYPE-2 DIABETES MELLITUS
Region
| Asia(except Japan) |
Condition
Condition
TYPE-2 DIABETES MELLITUS
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
TO COMPARE THE EFFECTIVENESS OF CENTISIMAL VERSUS FIFTY-MILLESIMAL SCALE IN THE MANAGEMENT OF TYPE-2 DIABETES MELLITUS
Basic objectives2
Others
Basic objectives -Others
1. To find out the most effective Individualized Homoeopathic Medicines in cases of T2DM patients
2. To find out the most suitable scale and potency in each individual case.
3. To assess the improvement in quality of life by using SF36 Questionnaire
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
According to Random Blood Sugar (RBS) levels compared at baseline and at the end of the study i.e., after 1 year in Group A (centesimal group), out of 30 patients, only 14 patients showed RBS levels within the normal range, 13 patients above the normal range, and 3 cases were dropped out, whereas, in Group B (fifty millesimal group), 22 patients showed RBS levels within normal range and only 6 patients above normal range and 3 cases were dropped out. Unpaired t-test was applied and p-value =0.0009 was obtained. Since the p-value < 0.05, the average of Group B's population is considered to be not equal to the average of Group-A's population. In other words, there is a statistically significant difference between RBS values in two treatment groups i.e., the Centesimal group and Fifty millesimal group. Fifty millesimal group (Group B) is effective in the treatment of Type II Diabetes Mellitus as compared to the Centesimal group (Group A).
Key secondary outcomes
Out of 60 patients, the most commonly indicated homoeopathic similimum medicine was Sulphur, Calcarea carbonica and Thuja occidentalis. In group A, most commonly indicated potency was 200 Centesimal, and in group B, in 50 percent of cases up to second fifty millesimal potency was most commonly indicated. The SF-36 questionnaire showed subjective improvement in all the domains after treatment in both groups. Group B (fifty millesimal group) was found to be more effective than Group A (centesimal group).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food | Behavior,custom |
Interventions/Control_1
Homoeopathic centesimal scale potency. Duration, amount, and frequency of intervention were based upon the severity of symptoms, susceptibility of the patient, and miasmatic background of the individual patient. The route of administration was oral.
Interventions/Control_2
Homoeopathic fifty millesimal scale potency. Duration, amount, and frequency of intervention were based upon the severity of symptoms, susceptibility of the patient, and miasmatic background of the individual patient. The route of administration was oral.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosed and stable cases of Type II Diabetes Mellitus under conventional treatment with Random Blood Sugar concentration more than 200 mg/dl, or Fasting plasma glucose more than 100 mg/dl, or HbA1C more than or equal to 6.5%.
Key exclusion criteria
TYPE 1 DM patients. TYPE 2 DM Patients suffering from any life-threatening illness and complicated diabetes mellitus. Patients who are terminally ill, under immunosuppressive treatment, or self-reported immunocompromised state. Patients of malignancy. Patients who were too sick for consultation. Diagnosed case of mental illness / psychiatric/ other uncontrolled/a life-threatening illness affecting the quality of life/any organ failure. Patients who were unable to comply with the study protocol (including psychiatric diseases). Pregnant ladies. Substance abuse and or dependence.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Dr PRIYANKA |
| Middle name | |
| Last name | MANGOTRA |
Organization
NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
Division name
DEPARTMENT OF HOMOEOPATHIC PHILOSOPHY AND ORGANON OF MEDICINE
Zip code
110024
Address
B BLOCK, DEFENCE COLONY, NEW DELHI, INDIA
TEL
7053083483
primangotra29@gmail.com
Public contact
Name of contact person
| 1st name | Dr PRIYANKA |
| Middle name | |
| Last name | MANGOTRA |
Organization
NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
Division name
DEPARTMENT OF HOMOEOPATHIC PHILOSOPHY AND ORGANON OF MEDICINE
Zip code
110024
Address
B BLOCK, DEFENCE COLONY, NEW DELHI, INDIA
TEL
7053083483
Homepage URL
primangotra29@gmail.com
Sponsor or person
Institute
NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
NIL
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
Address
B- BLOCK, DEFENCE COLONY, NEW DELHI, INDIA- 110024
Tel
+911124334225
principalnhmc@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL(NEW DELHI)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
An unpaired t test was applied inter-group RBS levels to compare the effectiveness between the two groups. The p-value equals to 0.00045 was obtained, since the p-value < 0.05, result is significant. Thus, null hypothesis is rejected. Fifty millesimal group (Group B) was found to be effective against Type II Diabetes Mellitus as compared to the Centesimal group (Group A).
Results date posted
| 2023 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
NO SUCH ADVERSE EFFECTS WERE RECORDED.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059058
