| CTRI Number |
CTRI/2024/10/074670 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic medicine Acidum Phosphoricum in reducing kidney damage in type 2 Diabetes Mellitus. |
|
Scientific Title of Study
|
The efficacy of Homoeopathic medicine Acidum Phosphoricum 30 in cases of Microalbuminuria in Diabetes Mellitus type 2 : A Comparative, Single blind, Prospective Case control 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. Mahak Baiwal |
| Designation |
Doctor, PG Scholar |
| Affiliation |
BVDU Homoeopathic Medical College, Department of Post Graduate And Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Dept. of Post Graduate and Research Centre, Pune-Bangalore Highway, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8103820088 |
| Fax |
|
| Email |
baiwalmahak12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr. Mrinal A Nerlekar |
| Designation |
MD(HOM), Head Of Dept. of Practice Of Medicine |
| Affiliation |
BVDU Homoeopathic Medical College, Department of Post Graduate And Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Dept. of Post Graduate and Research Centre, Pune-Bangalore Highway, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9422321397 |
| Fax |
|
| Email |
mrinal.nerlekar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Mahak Baiwal |
| Designation |
Doctor, PG Scholar |
| Affiliation |
BVDU Homoeopathic Medical College, Department of Post Graduate And Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Dept. of Post Graduate and Research Centre, Pune-Bangalore Highway, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8103820088 |
| Fax |
|
| Email |
baiwalmahak12@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVDU Homoeopathic Medical College and Hospital, Dept. of Post Graduation and Research Centre, Dhankawadi, Pune, Maharashtra, 411043 |
|
|
Primary Sponsor
|
| Name |
Dr Mahak Baiwal |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Dept. of Post Graduate and Research Centre, Pune-Bangalore Highway, Pune |
| 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 MAHAK BAIWAL |
BVDU Homoeopathic Medical College, Department of Post Graduation and Research centre |
Medicine OPD, Department of Practice of Medicine, Katraj, Dhankawadi, 411043, Pune
Pune
MAHARASHTRA |
8103820088
baiwalmahak12@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Bharati Vidyapeeth (DTU) HMC, PUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R809||Proteinuria, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acidum Phosphoricum 30 |
Potentised Homoeopathic Medicine Acidum Phosphoricum 30 in the form of pills or powder.
Dose: Acidum Phosphoricum based on symptom similarity will be prescribed in 30 potency and dose based on the susceptibilty of each individual case.
Route of Administration: Oral |
| Comparator Agent |
Sac Lac |
Sac Lac in the form of pills
Dose: Four pills twice a day for 12 days
Route of Administration - Oral |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed cases of diabetes mellitus type 2, already on anti- diabetics medication.
2.Age group of 35 years to 70 years.
3.Non hypertensive patients.
4.Patients with controlled sugar levels i.e. Fasting blood sugar level less than 140 and Post prandial blood sugar levels less than 180.
5.HbA1C less than or equal to 7.
6. Patients of all gender.
7. Albuminuria levels 30mg/g to 300mg/g i.e. moderate albuminuria.
8.Patients with no other complications of diabetes mellitus. |
|
| ExclusionCriteria |
| Details |
1.Age group below 35 years and above 70 years. 2.Mild and severe levels of albuminuria i.e. below 30mg/g and above 300mg/g. 3.Patients having other metabolic diseases like HTN and comorbidities, febrile illness, cancer. 4.Pregnant and lactating ladies. 5.Patients on any anti-fungal medications. 6.Patients with life threatening diseases who need emergency medical intervention. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check the efficiency of Acidum phosphoricum 30 on reducing microalbuminuria levels in type 2 diabetes mellitus. |
3 months with follow up in each 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know possible effects of Acid phosphoricum 30 in patients od diabetes mellitus. |
3 months with follow up in each 15 days. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
18/11/2024 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
This is a randomised clinical study to determine the effectiveness of homoeopathic potentised medicine Acidum Phosphoricum 30 in cases of microalbuminuria in diabetes mellitus type 2 in which the primary objective is to check the efficacy of Acidum phosphoricum 30 on reducing microalbuminuria levels in type 2 diabetes mellitus, also secondarily the effects of Acidum Phosphoricum 30 will be observed in diabetes mellitus patients. Minimum 50 patients at Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital will be enrolled in the study and will be randomly divided into two groups. One group will receive Acidum Phosphoricum 30 and the other group will receive Sac lac. Duration of the treatment will be for 3 months and follow up will be taken every 15 days and the assessment of the patient will be done by the albuminuria levels. |