| CTRI Number |
CTRI/2022/07/044488 [Registered on: 29/07/2022] Trial Registered Prospectively |
| Last Modified On: |
28/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EFFICACY OF HOMOEOPATHY IN CASES OF INSOMNIA WITH THE HELP OF ROBIN MURPHYS REPERTORY |
|
Scientific Title of Study
|
RANDOMISED CONTROL TRIAL OF HOMOEOPATHIC MEDICINE IN CASES OF INSOMNIA WITH THE HELP OF ROBIN MURPHYS REPERTORY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srabani Pal |
| Designation |
PhD Scholar |
| Affiliation |
Parul University |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital. Parul University. Limda. Waghodia. Vadodara. Sumandeep Homoeopathic Medical College and Hospital. Pipariya. Waghodia. Vadodara - 391760. Vadodara GUJARAT 391760 India |
| Phone |
9427341306 |
| Fax |
|
| Email |
drsrabanipal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jignesh Patel |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital. |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital. Parul University. Limda. Waghodia. Vadodara.
Vadodara GUJARAT 391760 India |
| Phone |
9909949221 |
| Fax |
|
| Email |
jhpatel2003@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Srabani Pal |
| Designation |
PhD Scholar |
| Affiliation |
Parul University |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital. Parul University. Limda. Waghodia. Vadodara. Sumandeep Homoeopathic Medical College and Hospital. Pipariya. Waghodia. Vadodara - 391760. Vadodara GUJARAT 391760 India |
| Phone |
9427341306 |
| Fax |
|
| Email |
drsrabanipal@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1 Jawaharlal Nehru Homoeopathic Medical College and
Hospital.
2 Sumandeep Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Parul University |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital. P.O.Limda. Waghodia - 391760. Vadodara. Gujarat. India. |
| Type of Sponsor |
Other [Private Homoeopathic Medical College and Hospital.] |
|
|
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 |
| DrSrabani Pal |
Jawaharlal Nehru Homoeopathic Medical College and Hospital. |
Jawaharlal Nehru Homoeopathic Medical College and Hospital. MEDICINE OPD. ROOM NO 110. Parul University. P.O.Limda. Waghodia - 391760. Vadodara. Gujarat. India. Vadodara GUJARAT |
9427341306
drsrabanipal@gmail.com |
| DrSrabani Pal |
Sumandeep Homoeopathic Medical College and Hospital. |
Sumandeep Homoeopathic Medical College and Hospital. MEDICINE OPD. 4th floor. Block 5. Sumandeep Vidyapeeth. Pipariya. Waghodia. Vadodara - 391760.Gujarat. India. Vadodara GUJARAT |
9427341306
drsrabanipal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homoeopathic Medical College and Hospital. Institutional Ethics Committee for Human Research. |
Approved |
| Sumandeep Homoeopathic Medical College and Hospital. Sumandeep Vidyapeeth. Pipariya. Waghodia. Vadodara - 391760.Gujarat. India. |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines selected with the help of Robin Murphys Repertory |
Individualization, selection of medicines, Dosage and instructions will be strictly following the homoeopathic principals. Each dose will be directed to be taken orally on clean tongue with empty stomach.
Duration of therapy :06 months. |
| Comparator Agent |
Placebo |
All the other instructions will be same as intervention arm except this arm will receive placebo . Each dose of placebo will be identical to centesimal, but will be prepared with
non-medicated globules. This need to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. The
patients will be advised to maintain adequate sleep hygiene, practice yoga, meditation, or exercise daily.
Duration of therapy: 06 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group considered from 18year to 60 years.
2.Both sexes were included.
3.Patient coming with any acute or chronic condition were taken up for the study.
4.Patients are only those considered for the study that is in mild and moderate insomnia.
5.Patient is in severe insomnia condition were only observed the frequency and intensity.
|
|
| ExclusionCriteria |
| Details |
1.Patients are on heavy dose of medicines of other system of medicine.
2.Patients having abnormal behavior were excluded.
3.Patients having severe pathological condition were excluded.
4.Neoplasm / malignancy.
5.Immune deficiency, Tuberculosis, any other severe infectious disease.
6.Emergency Cases of insomnia were excluded in my studies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep diary |
Monthly follow-up up to 06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Insomnia Severity Index (ISI) questionnaire. Utility of The Homeopathic Clinical Repertory by Robin Murphy |
Twelve Months |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
01/08/2022 |
| 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
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included drsrabanipal@gmail.com).
- For how long will this data be available start date provided 11-08-2022 and end date provided 11-12-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Insomnia is the complaint of poor sleep and usually presents as difficulty initiating or maintaining sleep. People with insomnia are dissatisfied with their sleep and feel it impairs their ability to function well. Affected individuals often experience fatigue, decreased mood, irritability, malaise, and cognitive impairment. Chronic insomnia, lasting >3 months, occurs in about 10% of adults. Acute or short-term insomnia affects over 30% of adults and is often precipitated by stressful life events. Most insomnia begins in adulthood, but many patients may be predisposed and report easily disturbed sleep predating the insomnia, suggesting that their sleep is lighter than usual. In this trial, the investigator intend to assess the efficacy of individualized homoeopathic treatment for insomnia using Murphy’s Repertory on 70 patients in a single blind, randomized, parallel arm, placebo controlled design in the outpatients of Jawaharlal Nehru Homoeopathic Medical College and Hospital. Parul University. P.O Limda, Tal: Waghodia, Dist: Vadodara, Gujarat State, India-391760 and Sumandeep Homoeopathic Medical College and Hospital under Sumandeep Vidyapeeth University. At & Po. Pipariya, Taluka Waghodia, Dist, Vadodara, Gujarat 391760 India. The patients will be prescribed either individualized homoeopathic medicines or identical placebo, and will be monthly followed up for 6 months. Data will be gathered at baseline and after 6 months using sleep diary and insomnia severity index questionnaire. Randomization will be computer generated. The collected data will be subjected to statistical analysis. The main aim is to prove utility of The Homoeopathic Clinical repertory by Robin Murphy. |