| CTRI Number |
CTRI/2025/07/090394 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Homoeopathy for sleep problems |
|
Scientific Title of Study
|
Individualized Homoeopathic treatment in Chronic
Primary Insomnia – A Pilot study |
| 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 Vaishali Shinde |
| Designation |
Research Officer S 3 |
| Affiliation |
Regional Research Institute for Homoeopathy, Kharghar, Navi Mumbai |
| Address |
Room no. 5,Ground Floor,Regional Research Institute for Homoeopathy, RRIU RRIH, Plot,38 39, Sector 18 Rd, Sector 18, Kharghar, Navi Mumbai, Maharashtra 410210
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9920425854 |
| Fax |
|
| Email |
drvhsb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research Officer Homoeopathy |
| Affiliation |
Central Council for Research in Homoeopathy,New Delhi |
| Address |
Room no.309,Central Council for Research in Homoeopathy ,D Block,Janakpuri,New Delhi West Delhi 110058 India
New Delhi
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renu Mittal |
| Designation |
Research Officer S 4 |
| Affiliation |
Central Council for Research in Homoeopathy,New Delhi |
| Address |
Room no.304,Central Council for Research in Homoeopathy, 61 65, Institutional Area, opp. D Block, Janakpuri,New Delhi 110058
New Delhi
DELHI
110058
India |
| Phone |
9717511115 |
| Fax |
|
| Email |
renumittal8@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy, New Delhi |
| Address |
Central Council for Research in Homoeopathy,61 65, Institutional Area, opp. D Block, Janakpuri, New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nidhi Mahajan |
Central Research Institute of Homoeopathy, Jaipur |
OPD No.3, Ground Floor, Department Homoeopathy, Division Clinical Research,RR4R MQ7, Sector 26, Pratap Nagar, Jaipur, Rajasthan 302033
Jaipur
RAJASTHAN |
9119124757
drnidhimahajan1@gmail.com |
| Dr Ramesh Bawaskar |
Regional Research Institute for Homoeopathy, Navi Mumbai |
Room no.01 Department- Homoeopathy, Division Clinical research Regional Research Institute for Homoeopathy, Mumbai, Plot No- 38 & 39, Sector- 18, Kharghar, Navi Mumbai-410210. Maharashtra.
Mumbai
MAHARASHTRA |
9769888743
drbrsb@gmail.com |
| Dr Vaishali Shinde |
Regional Research Institute for Homoeopathy, Navi Mumbai |
Room no.5,Ground Floor, Department Homoeopathy, Division Clinical Research, RRIH, Plot, 38 39, Sector 18 Rd, Sector 18, Kharghar, Navi Mumbai, Maharashtra 410210
Mumbai
MAHARASHTRA |
9920425854
drvhsb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMMITTEE |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| REGIONAL INSTITUTIONAL ETHICAL COMMITTEE |
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 |
Individualized Homoeopathic Medicines |
Individualized Homoeopathic Medicines in centesimal potency will be prescribed as per the principles of Homoeopathy. No new medicines will be used. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Participants of both sexes of age greater than 18 years visiting OPD of RRI Navi Mumbai and CRI Jaipur.
Willing to give consent for participation.
Participants presenting with complaints of sleep disorders hard to fall asleep stay sleep or wake up too early and not able to sleep back for at least 3 nights a week for last 3 months.
Participants whos sleep score with Insomnia Severity Index is ranging between 8 to 28 |
|
| ExclusionCriteria |
| Details |
Anyone who has any systemic illness such as Uncontrolled Diabetes, Hypertension, Seizures, Uncontrolled infections or any other vital organ failure.
Substance abuse and/or substance dependence.
Persons suffering from known psychiatric disease who are taking anti-psychotropic drugs.
Persons suffering from diseases causing sleep disturbances like BEP, Asthma, COPD, etc
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Change Insomnia Severity Scale (ISI)score. |
At Baseline , every 15 days follow up , at every month follow up.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Improve the quality of Sleep with decreasing Pittsburgh Sleep Quality Index (PSQI) score |
At baseline , at every month follow up |
| Outcome in Relation to Impact on Daily Living (ORIDL Scale) |
At every 15 days follow up , at every month follow up.
|
| Medicines that would be found useful in the three patterns of insomnia (as identified in the survey study). |
At Baseline , every 15 days follow up , at every month follow up.
|
|
|
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)
|
27/07/2026 |
| 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="0"
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
|
This prospective single arm pilot study is designed to evaluate the effectiveness of individualized homoeopathic intervention in patients suffering from chronic primary insomnia. The study will be conducted at the Regional Research Institute for Homoeopathy Navi Mumbai and the Central Research Institute of Homoeopathy Jaipur over a 12 month period. A total of 30 participants aged above 18 years meeting inclusion criteria based on Insomnia Severity Index scoring between 8 to 28 and chronic insomnia symptoms will be enrolled. Each participant will receive individualized homoeopathic medicines in centesimal potencies for four months with fortnightly follow ups. The primary outcome will be assessed using the Insomnia Severity Index ISI and secondary outcomes will include the Pittsburgh Sleep Quality Index PSQI and the Outcome in Relation to Impact on Daily Living ORIDL scale assessed at Baseline, every 15 day follow up and every monthly follow up. |