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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included drsrabanipal@gmail.com).

  6. 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.

  7. 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.  
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