| CTRI Number |
CTRI/2019/11/021931 [Registered on: 08/11/2019] Trial Registered Prospectively |
| Last Modified On: |
08/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines for sleep disturbance |
|
Scientific Title of Study
|
An open-label, randomized, placebo-controlled trial to evaluate the efficacy of Passiflora incarnata and individualized homeopathic medicines in insomnia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1241-9918 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fathima Rahim |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Materia Medica, OPD No. 13, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
9544499338 |
| Fax |
|
| Email |
fathima716homoeo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pratima Pal |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Materia Medica, OPD No. 13, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
7679507608 |
| Fax |
|
| Email |
dr.pratimapal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratima Pal |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Materia Medica, OPD No. 13, Block GE, Sector III, Salt Lake
WEST BENGAL
700106
India |
| Phone |
7679507608 |
| Fax |
|
| Email |
dr.pratimapal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India; Block GE, Sector III, Salt
Lake, Kolkata 700106, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India |
| 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 |
| Fathima Rahim |
National Institute of Homoeopathy |
Dept. of Materia
Medica, OPD room no.
13, Block GE, Sector III,
Salt Lake
Kolkata
WEST BENGAL |
9544499338
fathima716homoeo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Comparator Agent |
Individualized homeopathic medicines in centesimal or 50 millesimal potencies, as decided appropriate to the case or condition |
Comparator 1 is planned as administering individualized homeopathic medicines in centesimal or 50 millesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 6-8 medicated globules (no. 20) of cane sugar, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. In 50 millesimal scale, a single cane sugar globule of poppy seed size (no. 10) medicated with the individualized medicine in 50 millesimal potencies shall be dissolved in 80 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. The medicine needs to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. The patients will be advised to maintain adequate sleep hygiene, practice yoga, meditation, or exercise daily. Duration of therapy: 3 months. |
| Intervention |
Passiflora incarnata in centesimal or 50 millesimal potencies, as decided appropriate to the case or condition |
Intervention is planned as administering Passiflora incarnata in centesimal or 50 millesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 6-8 medicated globules (no. 20) of cane sugar, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. In 50 millesimal scale, a single cane sugar globule of poppy seed size (no. 10) medicated with Passiflora incarnata in 50 millesimal potencies shall be dissolved in 80 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. The medicine needs to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. The medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. The patients will be advised to maintain adequate sleep hygiene, practice yoga, meditation, or exercise daily. Duration of therapy: 3 months. |
| Comparator Agent |
Placebo, indistinguishable in appearance from verum |
This arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo will be identical to centesimal or 50 millesimal medicines in appearance, 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: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from insomnia for more than 3 months
2. Both sexes
3. Age 18-65 years
4. Literate patients with ability to read Bengali or English
5. Patients willing to participate in the study and giving written informed consent |
|
| ExclusionCriteria |
| Details |
1. Patients who are too unwell to take part
2. Inability to read patient information sheets and/or denied consent to take part
3. Diagnosed cases of unstable psychiatric complaints or other systemic diseases affecting quality of life
4. Currently receiving standard therapy for insomnia and/or homeopathic treatment for any chronic condition(s)
5. Pregnant and lactating women
6. Self-reported immune compromised conditions
7. Substance abuse and/or dependence |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep efficiency score derived from sleep diary |
Baseline, every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Daily sleep diary - five items |
Baseline, every month, up to 3 months |
| Insomnia Severity Index (ISI) |
Baseline, every month, up to 3 months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
18/11/2019 |
| 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) |
Open to Recruitment |
|
Publication Details
|
None yet; to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Insomnia is a prevalent condition associated with impaired day-time functioning, reduced quality of life, increased risk of morbidity and substantial societal cost. Numerous pharmacological and non-pharmacological therapeutic options exist. However, these treatments are not always fully effective and some have marked adverse effects. Because of this, many patients suffering from insomnia may try alternative therapies such as homeopathy. A systematic review was conducted to evaluate all randomized trials investigating the effectiveness of homeopathy for insomnia and sleep-related disorders. It concluded that the evidence from randomized trials does not show homeopathy to be an effective treatment for insomnia and sleep-related disorders. Subsequently, in a recent double blind, randomized, prospective, placebo-controlled, two parallel arms clinical trial on 60 patients suffering from insomnia at National Institute of Homoeopathy (NIH) produced significantly better effect than placebo. Thus in face of conflicting evidences and in order to explore the issues further, we aimed to evaluate the efficacy of Passiflora incarnata and individualized homeopathic medicines (IH) in comparison with placebo in 60 patients suffering from insomnia. The enrolled patients will be randomized in 1:1:1 ratio to either of the interventions – Passiflora incarnata (n=20), IH (n=20) or placebo (n=20). Sleep efficiency score of daily sleep diary will be the primary outcome, measured at baseline and every month up to 3 months. Rest of the sleep diary items and Insomnia Severity Index (ISI) will be the secondary outcomes, measured at baseline and every month up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. |