| CTRI Number |
CTRI/2025/09/094872 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicines in cases of increased blood sugar levels |
|
Scientific Title of Study
|
Effect Of Individualised Homoeopathic Medicines In Cases Of Prediabetes With Unavoidable Accessory Circumstances
In Adult Population - A Prospective Single Arm Interventional 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 |
Salika Shahid |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Organon Of Medicine second floor Bakson Homoeopathic Medical College Plot No 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
210310
India |
| Phone |
9810866514 |
| Fax |
|
| Email |
drsalikashahid@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashid Akhtar |
| Designation |
Guide and HOD |
| Affiliation |
Bakson Homoeopathic Medical college and Hospital |
| Address |
Room No S23 second floor Department of Organon Of Medicine Bakson Homoeopathic Medical College Plot No 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
210310
India |
| Phone |
9871894545 |
| Fax |
|
| Email |
rakhtar8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashid Akhtar |
| Designation |
Guide and HOD |
| Affiliation |
Bakson Homoeopathic Medical college and Hospital |
| Address |
Room No S23 second floor Department of Organon Of Medicine Bakson Homoeopathic Medical College Plot No 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
210310
India |
| Phone |
9871894545 |
| Fax |
|
| Email |
rakhtar8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital 36 B knowledge Park Phase 1 Greater Noida Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No. G22 Principal Office Ground Floor 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh 210310 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Salika Shahid |
Bakson Homoeopathic Medical College and Hospital |
Outpatient Department Room No 01 Ground Floor 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh 210310
Gautam Buddha Nagar
UTTAR PRADESH |
09810866514
drsalikashahid@gmail.com |
| Salika Shahid |
Dr D P Rastogi Central Research Institute (Homoeopathy) |
Outpatient department Room no 110, Dr D P Rastogi Central Research Institute A-1/1 Sector 24 Noida UP 201307
Gautam Buddha Nagar
UTTAR PRADESH |
09810866514
drsalikashahid@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homoeopathic Medical College and Hospital |
Approved |
| Kendriya Homoeopathic Anusandhan Parishad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R730||Abnormal glucose, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicines |
Medicines will be prescribed in centesimal or LM scale potency Oral route of administration either in pills form globule size 30 or liquid form in distilled water |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Participants with FBS between 100-125 mg/dl and/or OGTT between 140-199 mg/dl and/or HbA1c between 5.7%-6.4%
Participants with presence of one or more unavoidable accessory circumstances like chronic stress, poor sleep hygeine, emotional conflicts, occupational stress, family related strain etc.
Participants with no serious complications based on clinical evaluation
Participants who give their valid consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Participants who have diagnosed Type2 Diabetes Mellitus or any other systemic illness
Participants who are on other medications for some other medical conditions or on antidiabetic medication of some other system
Pregnant or lactating women
Participants with a known psychiatric illness
Participation in any other clinical trial during the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate changes in glycemic levels (FBS, OGTT, HbA1c) before and after homoeopathic intervention and document and analyse the types of unavoidable accessory circumstances considered during remedy individualisation |
The study duration will be 16 months
enrolment- 6 months
follow up- 6 months
data analysis- 2 months
report writing- 2 months
For statistical analysis
FBS and OGTT will be recorded at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks
and HbA1c- at baseline, 12weeks and 24 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate changes in the symptom burden using Diabetes Symptom Checklist- Revised |
baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/09/2025 |
| 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="4"
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 - NO
|
|
Brief Summary
|
This study aims to assess the effect of individualised
homoeopathic medicines selected with consideration of unavoidable accessory
circumstances on glycemic levels and its impact on daily living in prediabetic
individuals. It is a single arm study of 16 months duration in which 65 participants
will be enrolled and their level of FBS, OGTT, HbA1c and the symptom burden using
diabetes symptom checklist - revised will be recorded before and after homoeopathic
intervention. The patient’s perception of homeopathic treatment using ORIDL
scale will also be recorded. Analysis of data will be done using repeated
measure ANOVA at the end of 6 months. |