| CTRI Number |
CTRI/2023/10/058425 [Registered on: 06/10/2023] Trial Registered Prospectively |
| Last Modified On: |
03/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathy in treating Insomnia |
|
Scientific Title of Study
|
Role of Homoeopathic Medicines in case of 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 |
DR HIREN D PARMAR |
| Designation |
BHMS, MD SCHOLAR |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
DEPT. OF HOMOEOPATHIC MATERIA MEDICA, JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY,LIMDA,WAGHODIYA ROAD
Vadodara
GUJARAT
391760
India |
| Phone |
8758150080 |
| Fax |
|
| Email |
hiren160796@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR TARUN KUMAR DAS |
| Designation |
PROFESSOR,HEAD OF DEPARTMENT |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
DEPT. OF HOMOEOPATHIC MATERIA MEDICA, JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY,LIMDA,WAGHODIYA ROAD
Vadodara
GUJARAT
391760
India |
| Phone |
7984425115 |
| Fax |
|
| Email |
jnhmc@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR TARUN KUMAR DAS |
| Designation |
PROFESSOR,HEAD OF DEPARTMENT |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
DEPT. OF HOMOEOPATHIC MATERIA MEDICA, JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY,LIMDA,WAGHODIYA ROAD
Vadodara
GUJARAT
391760
India |
| Phone |
9227926514 |
| Fax |
|
| Email |
jnhmc@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL,PARUL UNIVERSITY,LIMDA,WAGHODIYA ROAD,VADODARA,GUJARAT-391760 |
|
|
Primary Sponsor
|
| Name |
DR HIREN D PARMAR |
| Address |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL,PARUL UNIVERSITY,LIMDA,WAGHODIYA ROAD,VADODARA,GUJARAT-391760 |
| 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 HIREN D PARMAR |
JAWAHARLAL NEHRU HOMOEOPATHIC HOSPITAL |
DEPT. OF MEDICINE, ROOM NO. 110, JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY,LIMDA,WAGHODIYA ROAD
Vadodara
GUJARAT |
8758150080
hiren160796@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
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 |
Coffea cruda,Kali phosphoricum,Ignatia amara,Cocculus indicus,Nux vomica,Opium,Hyoscyamus niger etc. |
Individualized Homoeopathic medicines like Coffea cruda,Kali phosphoricum,Ignatia amara,Cocculus indicus,Nux vomica,Opium,Hyoscyamus niger etc. are prescribed to the individuals having Insomnia, upon the basis of strict homoeopathic principles. Administration of the medicine will follow sublingual route. A Suitable potencies (30/200/1M etc.) will be prescribed as per the necessity of the case. Repetition of dose of Homoeopathic medicine will be done as per the requirement of the case. Dose will be administered and evaluated till the disappearance of the symptoms of insomnia. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. DSM-5 will be used for the diagnostic criteria of the case.
2. Cases of pre diagnosed or with clinical presentation of insomnia will be selected. |
|
| ExclusionCriteria |
| Details |
1. Cases having clinically gross pathological changes.
2. Cases with irregular follow up.
3. Suffering from sleep disorders other than insomnia.
4. Pregnant women and lactating mother.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. REDUCTION IN SYMPTOMS OF INSOMNIA.
2. IMPROVEMENT IN DAY TIME FUNCTIONING. |
15 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. REDUCTION IN INSOMNIA SEVERITY EVALUATED THROUGH INSOMNIA SEVERITY INDEX.
2. EVALUATE THE EFFECTIVENESS OF HOMOEOPATHIC MEDICINES IN CASES OF INSOMNIA. |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/10/2023 |
| 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="0"
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
|
Cases of Insomnia selected upon the basis of inclusion and exclusion criteria are administered with the Individualized Homoeopathic Medicines based upon the principles of Homoeopathy. This study aims to assess the utility of a Homoeopathic medicine for
treating cases of insomnia. This study will demonstrate statistically significant improvement in sleep, as measured by validated sleep assessment scale,i.e, INSOMNIA SEVERITY INDEX. We hypothesize that these improvements will be associated with reduced insomnia and enhanced daytime functioning among individuals with Insomnia. |