| CTRI Number |
CTRI/2024/06/069053 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study conducted on adult participants to improve sleep and to find out proper treatment plan based on Synthesis Repertory 9.1 for sleep disturbances in elder people through Homoeopathy. |
|
Scientific Title of Study
|
A Single Blind Randomised Controlled Trial for the Assessment and Treatment of Chronic Insomnia in Middle and Late adulthood population Based on Synthesis Repertory 9.1 |
| 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 RICHA S K |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room no 301, Department of Repertory, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
8778034916 |
| Fax |
|
| Email |
richuviji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A S SUMAN SANKAR |
| Designation |
Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room no 301, Department of Repertory, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443500675 |
| Fax |
|
| Email |
dissert02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A S SUMAN SANKAR |
| Designation |
Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room no 301, Department of Repertory, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443500675 |
| Fax |
|
| Email |
dissert02@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTION -Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamil Nadu 629161 |
|
|
Primary Sponsor
|
| Name |
Post Graduate research funded by institution |
| Address |
Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamil Nadu 629161 |
| Type of Sponsor |
Private medical college |
|
|
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 RICHA S K |
Sarada Krishna Homoeopathic Medical College |
Room no 301, Department of Repertory, Kulasekharam, Kanniyakumari District, Tamil Nadu
Kanniyakumari
TAMIL NADU |
8778034916
richuviji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE |
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 |
| Comparator Agent |
KALI PHOSPHORICA 6X |
Supplemented with biochemic remedy Kali phosphorica 6x for a period of 3 months (Follow up will be taken once in 15 days)and will also be provided with lifestyle modifications. |
| Intervention |
Medicine will be selected from Synthesis Repertory 9.1 |
Will be administered with medicine selected from Synthesis Repertory 9.1 with special emphasis to rubrics related to Chronic Insomnia for a period of 3 months (Follow up will be taken once in 15 days) and will be provided with lifestyle modifications |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
- Patients between 40 to 85 years of age
- Both Genders
- Patients with Insomnia Severity Index (ISI) above 7 will be included for the study
|
|
| ExclusionCriteria |
| Details |
- Patients Below 40 years of age
- Patients Above 85 years of age
- Patients undergoing treatment for severe systemic diseases.
- Patients undergoing treatment for psychiatric disorders such as depression, bipolar disorder, anxiety disorders and substance use disorders.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disappearance of symptoms presented in the patients with sleep disturbances by pre assessment and Post assessment using Insomnia Severity Index. |
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Reliability of rubrics related to sleep in Synthesis Repertory 9.1 for treating cases with chronic insomnia.
- Appearance of new symptoms in the patient after administration of similimum.
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/06/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a single blind randomised controlled trial for the assessment and treatment of Chronic Insomnia in middle and late adulthood population using Synthesis Repertory 9.1. The main objectives of the study is to evaluate the alterations in symptom presentation and to evaluate whether the Homoeopathic Similimum or Homoeopathic Biochemic remedy Kali phosphorica 6x produce significant effect in the treatment of Chronic insomnia. In this study, the patients (in between 40-85 years) presenting with significant sleep disturbances accompanied with daytime symptoms will be collected. Pre assessment of patients will be done using Insomnia Severity Index and scoring greater than 7 will be included for the study. Totality of Symptoms will be constructed and repertorised. There will be two groups: Intervention Group - Will be administered with medicine selected based on Synthesis Repertory 9.1 with special emphasis to rubrics related to Chronic Insomnia and will be provided with lifestyle modifications. Comparator Group - Will be administered with biochemic remedy Kali phosphorica 6x (Twice daily for the treatment period) and will also be provided with lifestyle modifications. Follow ups will be evaluated every 15 days for a duration of 3 months. Insomnia severity index measured at the baseline and after 3 months will be taken as the primary outcome of the study. |