| CTRI Number |
CTRI/2025/11/098110 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of homoeopathic medicine on sleep and blood sugar levels in people with type 2 diabetes mellitus having sleeplessness |
|
Scientific Title of Study
|
A prospective interventional study on the effect of individualized homoeopathic treatment on sleep quality and glycemic control in type 2 diabetes mellitus patients with insomnia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Inturi Lakshmi Durga |
| Designation |
post graduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy opd no 24 Department of Practice of medicine saltlake kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
8341839339 |
| Fax |
|
| Email |
inturi.lakshmi98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Inturi Lakshmi Durga |
| Designation |
post graduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy opd no 24 Department of Practice of medicine saltlake kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
8341839339 |
| Fax |
|
| Email |
inturi.lakshmi98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Gautam pal |
| Designation |
Professor and Head of Department Practice of Medicine |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy opd no 24 Department of Practice of medicine saltlake kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
7044524996 |
| Fax |
|
| Email |
drgautampal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, GE Block Sector 3 Salt lake |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
GE Block Sector 3 Salt lake Kolkata 700106 |
| Type of Sponsor |
Government medical college |
|
|
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 Inturi Lakshmi Durga |
National institute of homoeopathy |
National Institute of Homoeopathy opd no 24 Department of Practice of medicine saltlake kolkata
Kolkata
WEST BENGAL |
08341839339
inturi.lakshmi98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine |
Individualized homoeopathic medicine for 6 months in different potency according to patients need |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Type 2 Diabetes Mellitus according to American diabetes association 2024 criteria
Patients of type 2 diabetes mellitus meeting DSM 5 or ICSD 3 criteria for insomnia for at least 3 months
Patients with HbA1c levels ranging from 6.5 to 7.5 percentage
Patients of age 30 to 65 years of age irrespective of their gender race religion and socio- economic status
Pittsburgh sleep quality index score more than 5
Patient capable of giving informed consent willingness and ability to comply with scheduled visits treatment plans and other study procedures
Patients who are able to understand and communicate in the language used for data collection and consultations
|
|
| ExclusionCriteria |
| Details |
Patients with type 1 Diabetes Mellitus or other forms of secondary diabetes
Patients currently on insulin therapy or using any form of complementary or alternative medicine other than homeopathy for the management of diabetes or sleep disorders
Shift workers or individuals with irregular sleep patterns due to lifestyle or occupational reasons.
Patients who use sleep medications or antidepressants
Patients with unstable psychiatric illness uncontrolled or life-threatening medical conditions or clinically diagnosed complications related to type 2 diabetes mellitus that may affect quality of life
Pregnant or lactating women
Patients on substance abuse
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pittsburgh sleep quality index score |
At baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HbA1c levels |
Baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
03/12/2025 |
| 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="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 single-arm, prospective, interventional, non-randomized clinical study conducted over 18 months. Participants will be adults aged 30–65 years diagnosed with Type 2 Diabetes Mellitus as per ADA 2024 criteria, who also suffer from insomnia based on DSM 5 or ICSD 3 criteria for at least 3 months. Eligible participants will have HbA1c levels between 6.5 percent and 7.5 percent and a Pittsburgh Sleep Quality Index PSQI score greater than 5. They must be able to give informed consent, understand the study language, and comply with study procedures. Participants will be excluded if they have Type 1 or secondary diabetes, are on insulin or other alternative therapies (except homeopathy), use sleep medications or antidepressants, work irregular shifts, have serious medical or psychiatric conditions, pregnancy/lactation, or substance abuse. All eligible patients will receive individualized homeopathic medicines selected based on their characteristic symptoms and totality. Both centesimal and fifty millesimal potencies GMP-certified will be used, along with dietary advice for all participants.
|