| CTRI Number |
CTRI/2020/12/029964 [Registered on: 22/12/2020] Trial Registered Prospectively |
| Last Modified On: |
04/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homeopathic medicines to improve sleep quality in aged (60 years) people who are been elder abused and not abused. |
|
Scientific Title of Study
|
Role of Homoeopathic Medicines for improving Sleep Quality in Elder abused and Non- abused geriatric patients- A Randomized Single blind Comparative trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAKSHI MEHROTRA |
| Designation |
Asst. Prof. |
| Affiliation |
MNHMC & RI, BIKANER |
| Address |
M.N. Homoeopathic Medical college & R.I., Bikaner
OPD/IPD
Apna ghar ashram, Bikaner, Rajasthan
Bikaner
RAJASTHAN
334001
India |
| Phone |
9795561906 |
| Fax |
|
| Email |
sakshi.mehrotra15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaturbhuja Nayak |
| Designation |
Professor |
| Affiliation |
Former President at Homoeopathy University, Jaipur |
| Address |
Permanent address:
Plot No. N-5/385,
I.R.C. Village,
Nayapalli,
Bhubaneswar-754014,
Odisha.
Present address-
House no. 47-C
Block no. C-4-D,
Janakpuri
New Delhi- 110058
Puri
ORISSA
754014
India |
| Phone |
9958495858 |
| Fax |
|
| Email |
drcbnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAKSHI MEHROTRA |
| Designation |
Asst. Prof. |
| Affiliation |
MNHMC & RI, BIKANER |
| Address |
PG Deoartment of Materia Medica
M.N. Homoeopathic Medical college & R.I., Bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
9795561906 |
| Fax |
|
| Email |
sakshi.mehrotra15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mangilal Nirban Homoeopathic medical college and RI Bikaner,Jaipur-Jodhpur bypass, near Garden city, OPD |
|
|
Primary Sponsor
|
| Name |
MN Homoeopathic medical college RI Bikaner |
| Address |
Jaipur-Jodhpur bypass, Naino ka bass, Bikaner |
| 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 |
| Sakshi Mehrotra |
M.N. Homoeopathic Medical college & R.I., Bikaner |
OPD & IPD no. 3,23. Jaipur-Jodhpur bypass, Naino ka bass, Bikaner
Bikaner
RAJASTHAN |
9795561906
sakshi.mehrotra15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical comittee Homoeopathy University, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R54||Age-related physical debility, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homeopathic medicines |
Homeopathic medicines selected on the basis of totality of symptoms for Elder abused geriatric patients.
Dose and frequency will be selected on the basis of patients susceptibility.
Oral administration of the medicines.
Patients will be followed up for minimum 6 months duration. |
| Comparator Agent |
Homeopathic Medicines |
Homeopathic medicines selected on the basis of totality of symptoms for Non-Elder abused geriatric patients |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Elder abused and Non-abused (above 60 years of age) with reduced sleep quality. |
|
| ExclusionCriteria |
| Details |
1. Patients requiring emergency treatment.
2. Known case of Psychiatric conditions
3. Patients with clinical symptoms of Prostatitis, uncontrolled Diabetes Mellitus, which hamper the sleep quality due to waking during night hours due to frequency in micturition.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Homoeopathic medicines in improving sleep quality of elderly abused patients |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing role of homoeopathic medicines in imroving sleep quality of elderly abused and non-abused geraitric patients. |
1 year |
|
|
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)
|
25/12/2020 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Role of Homoeopathic Medicines for improving Sleep Quality in Elder abused and Non- abused Geriatric patients- A Randomized Single Blind Comparative Trial. This study will help homeopathic practitioners to help improve the sleep quality of the elderly abused and non-abused geriatric patients. A set of homeopathic remedies can be found effective in such cases. |