| CTRI Number |
CTRI/2025/02/080154 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic medicine in chronic insomnia |
|
Scientific Title of Study
|
Role of Antimiasmatic medicine in cases of chronic insomnia in age group 30 to 50 years assessed by Regensburg insomnia scale |
| 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 BHARATKUMAR BHIKHABHAI PATEL |
| Designation |
PG Scholar |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute |
| Address |
Department of Medicine Room no 6 ground Floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
8160391582 |
| Fax |
|
| Email |
bpatel6201@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANAND DESAI |
| Designation |
Professor |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute |
| Address |
Department of Organon of medicine Room no 16 Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
9429545666 |
| Fax |
|
| Email |
dranandjvb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BHARATKUMAR BHIKHABHAI PATEL |
| Designation |
PG Scholar |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute |
| Address |
Department of Medicine Room no 6 ground Floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
8160391582 |
| Fax |
|
| Email |
bpatel6201@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana Gujarat 384001 |
|
|
Primary Sponsor
|
| Name |
DR BHARATKUMAR BHIKHABHAI PATEL |
| Address |
Department of Medicine Room no 6 ground Floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana Gujarat 384001 |
| 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 BHARATKUMAR BHIKHABHAI PATEL |
Smt A J Savla Homoeopathic Medical College and Research Institute |
Department of Medicine Room no 6 ground Floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana 384001
Mahesana
GUJARAT |
8160391582
bpatel6201@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt A J Savla Homoeopathic Medical College and Research Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anti miasmatic Homoeopathic Medicine |
Potency various such as Centicimal Decimal 50 millesimal etc Doses as per need of cases Medicines will be Dispended as per potency Frequency as per the Need of cases Route of administration oral Duration of Therapy is 6 months or as per the need of Case |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Complain of sleep disturbances up to 3 months to 1 year
Patient having chronic insomnia only due to anxiety stress and depression
RIS (Regensburg insomnia scale) score up to 15 to 30
Patient who give consent as able to fill Regensburg insomnia scale
|
|
| ExclusionCriteria |
| Details |
Having any general pathological disease which causes insomnia like Cancer Parkinson disease and any other sleep disorder
Having any major psychiatric illness like schizophrenia bipolar disorder ADHD
Taking any other medications related to insomnia
Taking tobacco cigarette smoking and alcohol
For Female taking any hormonal pills pregnancy and menopausal symptoms
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Insomnia will assessed with Regensburg Insomnia Scale |
Regensburg Insomnia Scale will assessed at baseline and every month upto 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2025 |
| Date of Study Completion (India) |
15/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 IS PROSPECTIVE STUDY PRE TEST POST TEST ONE GROUP EXPERIMENTAL STUDY TO ASSESS THE ROLE OF ANTIMIASMATIC HOMOEOPATHIC MEDICINES FOR 6 MONTHS IN 40 PARTICIPANTS WITH CHRONIC INSOMNIA THAT WILL BE CONDUCTED AS PER INCLUSION AND EXCLUSION CRITERIA FROM OUT PATIENT DEPARTMENT AND THE PRIMARY OUTCOME MEASURE WILL ASSESS THE REDUCTION OF SEVERITY OF SCORE OF CHRONIC INSOMNIA OF PARTICIPANTS USING REGENSBURG INSOMNIA SCALE SCORE AT BASELINE AND EVERY 1 MONTH UPTO END OF TREATMENT FOR 6 MONTHS FOLLOW UP AS PER NEED OF CASE FOR 6 MONTHS OF DURATION |