| CTRI Number |
CTRI/2018/04/013272 [Registered on: 13/04/2018] Trial Registered Prospectively |
| Last Modified On: |
13/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homeopathic treatment of vaginal symptoms after menopause |
|
Scientific Title of Study
|
An open observational trial of individualized homoeopathic treatment of vulvovaginal symptoms in post-menopausal women and validation of the translated Vulvo-vaginal Symptom Questionnaire in Bengali language |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1212-1126 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhranil Saha |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Department of Case Taking & Repertory, OPD room no. 11, Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9831063837 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhranil Saha |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Department of Case Taking & Repertory, OPD room no. 11, Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9831063837 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhranil Saha |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Department of Case Taking & Repertory, OPD room no. 11, Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9831063837 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College & Hospital, Govt. of West Bengal |
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| The Calcutta Homoeopathic Medical College & Hospital, Govt. of West Bengal |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy Ministry of AYUSH Govt of India |
| Address |
Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital Govt of west Bengal |
Drainage Canal Road, Doomurjala, Howrah 711104, West Bengal, India |
| The Calcutta Homoeopathic Medical College Hospital Govt of West Bengal |
265-266, APC Road, Kolkata 700009, West Bengal, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amila Modak |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal |
OPD no. 5, Dept. of
Obstetrics & Gynaecology, Drainage Canal Road, Doomurjala, Howrah 711104, West Bengal
Haora
WEST BENGAL |
9433432025
amilamodak@gmail.com |
| Ompriya Mishra |
National Institute of Homoeopathy, Govt. of India |
OPD no. 4, Dept. of
Obstetrics & Gynaecology, Block
GE, Sector III, Salt Lake, Kolkata 700106
Kolkata
WEST BENGAL |
9432496545
drompriyanih@gmail.com |
| Sangita Saha |
The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal |
OPD no. 4, Dept. of Obstetrics & Gynaecology, 265-266, APC Road, Kolkata 700009, West Bengal
Kolkata
WEST BENGAL |
9433849505
dr.sangita@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Mahesh Bhattacharyya Homoeopathic Medical College Hospital |
Approved |
| Institutional Ethics Committee of National Institute of Homoeopathy |
Approved |
| Institutional Ethics Committee of The Calcutta Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Postmenopausal vulvo-vaginitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indicated homoeopathic medicines in centesimal or fifty
millesimal potencies |
Indicated homoeopathic
medicines in centesimal or fifty millesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of a single drop of the indicated medicine (preserved in 90% v/v
ethanol) in 5 ml of distilled
water, to be taken orally;
dosage and repetition depending upon the individual
requirement of the cases. In 50 millesimal scale, a single
medicated cane sugar globules
of poppy seed size (no. 10)
shall be dissolved in 90 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. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. All medicines should be taken on clean tongue in empty stomach.
Along with medicines, the
patients will receive dietary
advice. Duration of therapy: 3 months. |
| Comparator Agent |
None |
NA |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Postmenopausal women suffering from vulvo-vaginal symptoms for at least last 3 months
2. Age: 50-60 years
3. Ability to read Bengali
5. Patients giving written consent to participate
6. Any standard or other CAM therapy, if ongoing, discontinued for at least 1 month |
|
| ExclusionCriteria |
| Details |
1. Patients with known vulvar dermatoses including: Lichen Sclerosus, Lichen Planus, Psoriasis, Behcet’s disease, Hidradenitis Suppurativa, Anorectal Crohn’s disease, or Genital Herpes
2. Patients who had an artificial menopause and were on HRT
3. Patients having history of breast or reproductive organ cancer
4. Major gynecological surgery in last 6 months
5. Patients with psychiatric diseases.
6. Cases suffering from uncontrolled systemic illness or life-threatening infections
7. Cases already undergoing homoeopathic treatment for any chronic disease
8. Substance abuse and/or dependence
9. Self-reported immune-compromised state |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Translated Bengali version of vulvo-vaginal symptom questionnaire (VSQ) |
Baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Translated Bengali version of Utial Quality of Life (UQOL) questionnaire |
Baseline and after 3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
23/04/2018 |
| 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
|
Menopause is the final menstrual period, and occurs at an average age of 51 years. Menopause is defined as the permanent cessation of menstrual cycles where pathological causes of this state can be diagnosed. Demographic data shows that every year 25 million women worldwide experience menopause. An estimated 75%
of women experience at least one episode of vulvovaginal candidiasis (VVC) during their lifetimes. Nearly 45% of women will experience two or more episode. Candida albicans is responsible for 85% to 90% of vaginal yeast infections. Other species of candida such as C. glabrata, and C. tropicalis can cause vulvovaginal symptoms and to be resistant to therapy. Menopausal symptoms have been treated with homoeopathic medicines for more than one and a half centuries. In spite of
promising potentials of homoeopathic treatment of menopausal syndrome, it has remained anecdotal rather than being evidence-based. Individualized homoeopathic treatment may have considerable potential to offer in successful treatment of vulvo-vaginal symptoms in post-menopausal women, but has remained under-researched till date. In this open, observational, multicentric, pre-post comparison clinical trial, 100 patients suffering from post-menopausal vulvo-vaginitis will be given individualized homoeopathic medicines to examine treatment effect over 3 months. Prior to that, psychometric validity of the translated Bengali versions of the vulvo-vaginal symptoms questionnaire (VSQ) and Utian Quality of Life (UQOL) questionnaire will be tested. Results will be published in scientific journals.
|