| CTRI Number |
CTRI/2025/05/086940 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Utility of Individualised Homoeopathic Medicine in Cases of Hypersomnia. |
|
Scientific Title of Study
|
To Study Utility of Individualized Homeopathic Medicine In Cases Of Hypersomnia Using Homeopathic Medical Repertory By Dr. Robin Murphy |
| 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 Ripalkumar Gohil |
| Designation |
BHMS PG Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Room No 401 A PG Department of Case taking And Repertory, Jawaharlal Nehru Homoeopathic Medical College, Parul University, P.O.Limda, Ta. Waghodia , Dis. Vadodara, Gujarat, 391760
Vadodara GUJARAT 391760 India |
| Phone |
9624772392 |
| Fax |
|
| Email |
2304082030002@paruluniversity.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jignesh Patel |
| Designation |
Head Of Department ,Department Of Case Taking And Repertory |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Room No 401 A Department of Case taking And Repertory, Jawaharlal Nehru Homoeopathic Medical College, Parul University, P.O.Limda, Ta. Waghodia , Dis. Vadodara, Gujarat, 391760
Vadodara GUJARAT 391760 India |
| Phone |
9909949221 |
| Fax |
|
| Email |
jignesh.patel79013@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Jignesh Patel |
| Designation |
Head Of Department ,Department Of Case Taking And Repertory |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Room No 401 A Department of Case taking And Repertory, Jawaharlal Nehru Homoeopathic Medical College, Parul University, P.O.Limda, Ta. Waghodia , Dis. Vadodara, Gujarat, 391760
Vadodara GUJARAT 391760 India |
| Phone |
9909949221 |
| Fax |
|
| Email |
jignesh.patel79013@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College, Parul University, P.O. Limda, Ta. Waghodia, Dist. Vadodara, Gujarat, India
Pin Code 391760
|
|
|
Primary Sponsor
|
| Name |
Dr Ripalkumar Gohil |
| Address |
Jawaharlal Nehru Homoeopathic Medical College, Parul University, P.O. Limda, Ta. Waghodia, Dist. Vadodara, Gujarat, India, India
Pin Code- 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 Ripalkumar Gohil |
Jawaharlal Nehru Homoeopathic Medical College And Hospital |
OPD Room NO. 110, Jawaharlal Nehru Homoeopathic Medical College And Hospital, Parul University, P.O. Limda, Ta. Waghodia, Dis. Vadodara, Gujarat, 391760 Vadodara GUJARAT |
9624772392
ripalgohil126@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homoeopathic Medical college( Institutional Ethics Committee For Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G471||Hypersomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized Homoeopathic Medicine in 30,200,1M Potency BD or TDS for 15 days for 3 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the DSM 5 criteria Of Hypersomnia.
2. Pre Diagnosed Cases Of Hypersomnia.
3. Age Between 18 years to 70 years.
4. Both Male and Female Gender are Included.
5. All socio economic class Patients. |
|
| ExclusionCriteria |
| Details |
1. Patients Who Does not give Consent.
2. Excessive Day time sleepiness Due to Insomnia.
3. Pregnant and Lactating Women.
4. Patient with Severe Systemic Disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study effectiveness of Individualised Homeopathic medicine selected in cases of
Hypersomnia using Homoeopathic medical repertory by Dr. Robin Murphy. |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Assess the outcome in sleepiness using Epworth sleepiness scale after prescribing
individualized Homeopathic medicine. |
3 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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="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
|
Hypersomnia is a sleep disorder marked by excessive daytime sleepiness (EDS), prolonged nighttime sleep, irresistible and refreshing sleep episodes, and difficulty waking up. It can significantly impair daytime alertness and overall quality of life. According to the ICD-11, it is classified under code 7A21. Surveys indicate that up to 25% of adults experience persistent daytime sleepiness, with moderate EDS affecting around 15% and severe EDS around 5% of the general population. In India, EDS prevalence ranges from 5–10% in the general population and up to 80% among working professionals like doctors, nurses, and IT workers.
Homeopathy, based on the principle of treating the individual rather than the disease, utilizes potentized remedies to stimulate the body’s vital force and restore homeostasis. In this context, individualized Homeopathic treatment offers potential in managing Hypersomnia effectively, similar to its application in other sleep disorders such as insomnia.
Dr. Robin Murphy’s Homeopathic Medical Repertory, which incorporates classical and clinical approaches including Kent’s generals and Boenninghausen’s methodology, offers more than 500 rubrics related to sleepiness. Its Constitution chapter aids in accurate remedy selection. Despite the significance of Hypersomnia and the comprehensive nature of Murphy’s repertory, no clinical studies in India have evaluated its application in managing Hypersomnia.
This study aims to assess the effectiveness of individualized Homeopathic remedies selected using Murphy’s Repertory in treating Hypersomnia. The Epworth Sleepiness Scale (ESS), a validated 8-item questionnaire, will be employed to assess sleepiness severity. The research seeks to bridge the gap in Indian literature on Homeopathic treatment of Hypersomnia and provide valuable clinical data. It is anticipated that individualized Homeopathic intervention will alleviate symptoms, improve quality of life, and reduce the burden of Hypersomnia in affected individuals. |