| CTRI Number |
CTRI/2024/08/072878 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A longitudinal assessment of continuity hypothesis of dreaming |
|
Scientific Title of Study
|
A longitudinal assessment of continuity hypothesis of dreaming by comparing dream content
with overall health status and its homoeopathic management A mixed method 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 Shunmathy S M |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD 24, Department of Practice of Medicine, National Institute of Homoeopathy, Block GE, Sector III, Salt lake, Kolkata, West Bengal 700106.
Kolkata
WEST BENGAL
700106
India |
| Phone |
9566938981 |
| Fax |
|
| Email |
priyashunmathy1709@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautam Pal |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD 24, Department of Practice of Medicine, National Institute of Homoeopathy, Block GE, Sector III, Salt lake, Kolkata, West Bengal 700106.
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433902556 |
| Fax |
|
| Email |
drgautampal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautam Pal |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD 24, Department of Practice of Medicine, National Institute of Homoeopathy, Block GE, Sector III, Salt lake, Kolkata, West Bengal 700106.
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433902556 |
| Fax |
|
| Email |
drgautampal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Kolkata, West Bengal. |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy, Block GE, Sector III, Salt lake, Kolkata, West Bengal 700106. |
| Type of Sponsor |
Government 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 Shunmathy S M |
National Institute of Homoeopathy |
OPD number 24, Department of Practice of Medicine, National Institute of Homoeopathy, Block GE, Sector III, Salt lake, Kolkata, West Bengal 700106
Kolkata
WEST BENGAL |
9566938981
priyashunmathy1709@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of the National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicines |
All eligible patients will be prescribed with homoeopathic medicines (in various potencies) which will
be selected primarily based on their characteristic dream content. Relevant investigations procedures and general management instructions will be advised to the patient
based on their clinical conditions. Follow up will be done monthly till 6 months from the baseline. Dose and potency will be based on each patients susceptibility. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
i. Patients having a minimum of three similar and/or characteristic dreams in the past one month
ii. Patients of age 18 – 65 years, irrespective of their sex, race, religion and socio-economic
status
iii. Patients who are literate
iv. Patient must be capable of giving informed consent
v. Willingness and ability to comply with scheduled visits, treatment plans and other study
procedures
|
|
| ExclusionCriteria |
| Details |
i. Patients who are diagnosed with an unstable mental or psychiatric illness or other
uncontrolled or life-threatening diseases that affect the quality of life
ii. Patients with any gross pathology or organ failure
iii.Pregnant or lactating women
iv. Patients using drugs or alcohol excessively or depended on them
v. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality
that would impart, in the judgment of the investigator, excess risk associated with study
participation or medicine prescription, or which would make the patient inappropriate for
entry into this study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To analyse the correlation between the dream content and the overall health status by using Hall
and Van De Castle coding system for the quantitative dream content analysis and The Medical
Outcomes Short Form 36 (SF-36) health survey questionnaire |
Baseline and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of homoeopathic medicines which are prescribed by giving utmost
importance to dream content in changing The Medical Outcomes Short Form 36 (SF-36) health
survey score over a 6 months’ period of treatment. |
Baseline and six months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/08/2024 |
| Date of Study Completion (India) |
29/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The selected patients will be included in the study according to the inclusion and exclusion criteria. A
minimum of 30 eligible patients having characteristic dreams (minimum of three similar dreams in
the past one month) will be recruited to participate in the study. During the first month, the dream reports given by the patients will be translated to English language and then coded into various categories by using
the Hall and Van De Castle coding system for quantitative dream content analysis. During the same
visit, the patient will be assessed for their overall health status by the Medical Outcomes Short Form
(SF-36) health survey questionnaire. Correlation between the patients’ dream content and their overall
health status will be analysed by comparing the various subscales of SF-36 survey with various
categories mentioned in Hall and Van De Castle coding system. At the end of six months, every patients’ overall health
status will be assessed again by using the SF-36 health survey and effectiveness of homoeopathic
medicines will be evaluated. |