| CTRI Number |
CTRI/2017/06/008849 [Registered on: 16/06/2017] Trial Registered Prospectively |
| Last Modified On: |
20/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of low back pain after caesarean delivery |
|
Scientific Title of Study
|
The role of homoeopathic treatment in individuals suffering from backache following caesarean section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arunava Nath |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD No. 5, Dept. of Organon of Medicine, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
9339444585 |
| Fax |
|
| Email |
arunava_nath80@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahadeb De |
| Designation |
Reader, Dept. of Organon of Medicine |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Dept. of Organon of Medicine, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
9831138007 |
| Fax |
|
| Email |
mail2mahadebde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahadeb De |
| Designation |
Reader, Dept. of Organon of Medicine |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Dept. of Organon of Medicine, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake
WEST BENGAL
700106
India |
| Phone |
9831138007 |
| Fax |
|
| Email |
mail2mahadebde@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 Ministry of AYUSH Govt of India |
| 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 |
| Arunava Nath |
National Institute of Homoeopathy, Govt. of India |
OPD Room no. 5, Dept. of Organon of Medicine, National Institute of
Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106,
India; Monday to
Saturday, 9 am to 2 pm
Kolkata
WEST BENGAL |
9339444585
arunava_nath80@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Backache following caesarean section, (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic
medicine in centesimal or 50
millesimal potencies |
In centesimal potencies, each dose shall consist of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 88% v/v
ethanol. In 50 millesimal
potencies, a single medicated cane sugar globules of poppy seed size (no.10) dissolved in 50 ml distilled water with
addition of 2 drops of 88% v/v ethanol, 10 doses 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 in the cup.
Repetition 24, 12 or 8 hourly or even oftener, depending upon the individual requirement of the case. Each dose to be taken orally on clean tongue in empty stomach. Duration of therapy: 3 months |
| Comparator Agent |
None |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients suffering from backache over 3 months following caesarean section
2. Female subjects of reproductive age group of 18-45 years
3. Patients willing to take part in the study and giving written consent |
|
| ExclusionCriteria |
| Details |
1. Patients who are too sick for consultation
2. Unable to read patient information sheets and not giving consent to take part
3. Postmenopausal women
4. Subjects presenting with confounding variable like pre-existing backache before Caesarean Section
5. Subjects with immediate complications after Caesarean Section
6. Diagnosed cases of unstable psychiatric illness or other systemic disease affecting quality of life
7. Currently receiving homeopathic treatment for chronic condition(s)
8. Pregnant and lactating women
9. Self-reported immune-compromised state
10. Substance abuse and/or dependence |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Short form McGill Pain Questionnaire (SF-MPQ; translated Bengali version) |
Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry Low Back Pain Questionnaire (translated Bengali version) |
Baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/06/2017 |
| Date of Study Completion (India) |
28/08/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nath A, De M, Singh S, Kundu N, Michael J,
Sadhukhan S, et al. The role of homoeopathic treatment in women suffering
from post-caesarean backache: An open observational clinical trial. Indian
J Res Homoeopathy 2019;13:81-90. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Context: An open observational trial
was carried out at National Institute of Homoeopathy, India, to assess the
possible effects of individualised Homoeopathy in individuals suffering from
post-caesarean backache. Aim: The
aim of the study was to find the role of homoeopathic treatment in
individuals suffering from post-caesarean backache. Methods:
Fifty subjects were enrolled. The Short-Form
McGill Pain Questionnaire (SF-MPQ) and Oswestry Low Back
Pain Disability Questionnaire (ODQ) were used as the outcome measures, assessed
at baseline and after 3 months of treatment. Medicines prescribed followed
homoeopathic principles. Non-parametric Wilcoxon signed rank test was applied
to compare the dependent observations. P < 0.05 two-tailed was considered statistically significant. Results:
Five subjects dropped out and 45
completed the trial. Intention-to-treat sample (n = 50) was analysed. There were
statistically significant reductions in pain rating index percentage score
(median 83.3 (IQR 66.7 to 100) vs. median 66.7 (IQR 33.3 to 71.1), P <
0.001); visual analogue scale score (median 7.0 (IQR 6.0 to 8.0)
vs. median 6.0 (IQR 4.8 to 7.0), P < 0.001); present pain index score
(median 3.0 (IQR 2.0 to 3.0) vs. median 2.0 (IQR 2.0 to 3.0), P = 0.019)
and ODQ% score (median 44.0 (IQR 39.5 to 50.0) vs. median 39.0 (IQR 31.9 to
44.0), P < 0.001) over 3 months of treatment. Natrum muriaticum (n
= 11, 22%); Staphysagria (n = 8, 16%); Bryonia alba and
Rhus toxicodendron (n = 6 each, 12%) and Pulsatilla nigricans
(n = 4, 8%) were prescribed frequently. Conclusion: Indicated
homoeopathic medicines reduced SF-MPQ and ODQ scores. Further randomised trials are
warranted with enhanced methodological rigour. |