| CTRI Number |
CTRI/2020/11/028796 [Registered on: 02/11/2020] Trial Registered Prospectively |
| Last Modified On: |
07/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of Premenstrual Syndrome |
|
Scientific Title of Study
|
Individualized Homoeopathic Medicines in Treatment of Premenstrual Syndrome: Double- blind, Randomized, Placebo-controlled, Pilot Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjib Sahoo |
| Designation |
Postgraduate trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Dept of Materia Medica, OPD room no. 12, Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
8159802601 |
| Fax |
|
| Email |
pmsanjibsahoo970@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chintamani Nayak |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Dept of Materia Medica, OPD room no. 12, Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chintamani Nayak |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Dept of Materia Medica, OPD room no. 12, Block GE, Sector III, Salt Lake, Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy Ministry of AYUSH Govt of India |
| Address |
Block-GE, Sector-III, Salt lake, PIN-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 |
| Sanjib Sahoo |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
Dept of Materia Medica, OPD room no. 12, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL |
8159802601
pmsanjibsahoo970@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: N943||Premenstrual tension syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic
medicines in centesimal
potencies |
Each dose shall consist of 6-8 globules (no. 20) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) 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. Duration of therapy: 3 months. |
| Comparator Agent |
Placebo |
Each dose of placebo shall consist of 6-8 globules (no. 20) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Cases suffering from PMS for more than 3 months, diagnosed as per ICD-10 criteria
2. Patients taking oral contraceptive pills (OCPs) will be advised to stop pills till it exhaust for the ongoing cycle, followed by reassessment of PMS symptoms in the next cycle enrolment
3. Patients under hormonal replacement therapy (HRT) to be included after a washout period of 3 months
4. Literate patients; ability to read Bengali and/or English
5. Patients giving written consent to participate |
|
| ExclusionCriteria |
| Details |
1. PMDD states
2. Patients underwent a hysterectomy and/or bilateral oophorectomy
3. Primary or secondary amenorrhoea
4. Change in hormone status (introduction of oestrogen and/or progestogen, amenorrhoea, pregnancy etc.)
5. Patients having a history of breast or reproductive organ cancer
6. Unevaluated gynaecological abnormalities; e.g. unexplained vaginal bleeding, cervical dysplasia, pelvic inflammatory diseases (PID) within
one month, patients with suspicious adenomyosis, gross developmental defect or congenital abnormalities of the uterus etc.
7. Patients with psychiatric diseases
8. Cases suffering from uncontrolled systemic illness, life-threatening
infections, or any vital organ failure
9. Patients insisting to use OCPs and HRT
10. Cases already undergoing homoeopathic treatment for any chronic purpose
11. Substance abuse and/or dependence
12.Self-reported immune-compromised state |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shortened Premenstrual Assessment Form (SPAF) |
Baseline, 1 month, 2 month, 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
participant-rated Premenstrual Tension
Syndrome Visual Analogue Scale (PMTS-VAS) |
Baseline, 1 month, 2 month, 3 month |
Premenstrual Tension Syndrome
Observer Rating Scale – Revised (PMTS-OR) |
Baseline, 1 month, 2 month, 3 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/11/2020 |
| Date of Study Completion (India) |
09/03/2022 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Premenstrual syndrome (PMS) is one of the commonest problems in females of reproductive age group. This pilot trial aimed at testing the feasibility of future definitive trial and evaluated whether individualized homoeopathic medicines (IH) have a significant effect beyond placebo in PMS symptoms. A double-blind, randomized (1:1), placebo-controlled, parallel arms, a pilot trial will be conducted at National Institute of Homoeopathy, Kolkata, West Bengal, India. Patients received either IH (n=30) or identical-looking placebo (n=30) during the trial. Outcomes will be measured every month up to 3 months. Group differences will be estimated by intention-to-treat analysis. The trial results will enable us to understand the effect of homoeopathic medicines in PMS, the feasibility of conducting such trials in future and direction to the future studies. |