| CTRI Number |
CTRI/2024/05/066936 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment for
emotional dysregulation of women with chronic
pelvic pain from gynaecological disorders. |
|
Scientific Title of Study
|
Role of individualized homoeopathic medicine in
emotional dysregulation of women with chronic
pelvic pain from gynaecological disorders- a single
arm pre-post clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Likhi Prasannan |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy. |
| Address |
OPD room no: 14 & 31, Department of Organon of Medicine.
National Institute of Homoeopathy, GE Block, Sector - III, Salt lake, Kolkata - 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
9496355249 |
| Fax |
|
| Email |
mail2likhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ompriya Mishra |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy. |
| Address |
OPD room no: 31,
Department of Obstetrics and Gynaecology, National Institute of Homoeopathy, GE Block, Sector - III, Salt lake, Kolkata - 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
8240359414 |
| Fax |
|
| Email |
drompriyanih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Ompriya Mishra |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy. |
| Address |
OPD room no: 31,
Department of Obstetrics and Gynaecology, National Institute of Homoeopathy, GE Block, Sector - III, Salt lake, Kolkata - 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
8240359414 |
| Fax |
|
| Email |
drompriyanih@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, GE Block, Sector- III, Salt lake, Kolkata- 700106
|
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy. |
| Address |
GE Block, Sector- III, Salt lake, Kolkata- 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 |
| Dr Likhi Prasannan |
National Institute of Homoeopathy |
OPD no: 14 and 31, Department Of Organon of Medicine, GE Block, Sector – III, Salt Lake, Kolkata – 700106
Kolkata
WEST BENGAL |
9496355249
mail2likhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R102||Pelvic and perineal pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine in suitable potency. |
All patients will be prescribed individualized homoeopathic medicine after detailed case
taking in accordance with the directions given by Dr. C.F.S Hahnemann in ‘Organon of
Medicine’6th Edition. Indicated individualized homoeopathic medicine in suitable potency will be prescribed. Dose and frequency of medicine will be decided as per the homoeopathic principles. Follow up will be done monthly till 6 months from the baseline. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients with chronic pelvic pain having clinical symptoms of gynaecological
disorders, with or without findings in ultrasonography abdomen and pelvis.
2. Female patients of 18- 50 years of age
3. Patients with chronic pelvic pain showing any findings of gynaecological disorders in
ultrasonography abdomen and pelvis.
4. Patients who score 19 or below in cognitive reappraisal and 7 or above for expressive
suppression in Emotion Regulation Questionnaire (ERQ) 32
5. Patients who can read/ understand either English, Hindi, Bengali.
6. Patients who are willing to participate in study and giving written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Patient suffering from pelvic pain only during menstrual cycle.
2. Patients who have attained menopause
3. Patients suffering from chronic pelvic pain due to urological, gastrointestinal,
musculoskeletal or neurological disorders.
4. Patients who are pregnant, lactating, taking OCP or done hysterectomy.
5. Patients who are taking medications for any other chronic disease.
6. Patients who are diagnosed with life threatening diseases, systemic illness, immunocompromised states, psychiatric illness and malignancy.
7. Substance abuse and/or dependence. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difficulty in Emotion Regulation Scale. (DERS) |
Baseline and 6th month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Pelvic Pain Scale (FPPS) |
Baseline and 6th month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic Pelvic Pain (CPP) is persistent pelvic pain for at least 6 months and is severe enough to cause functional disability and lead to medical care. CPP cannot be viewed as single entity, rather a constellation of predisposing factors and altered mechanism, is an important presenting symptom that can arise from a diverse group of disorders. The incidence of CPP associated with gynaecological disorders are probably in excess. Gynaecological comorbidities are seen in an estimated twenty percent of patients with chronic pelvic pain. Specific gynaecological conditions that can cause CPP include endometriosis, pelvic adhesions, chronic pelvic inflammatory diseases, ovarian remnant, pelvic congestion syndrome and adenomyosis. The prevalence of CPP is approximately between four to sixteen percent of women. Up to 24% of women globally suffer from CPP. Emotion regulation plays a vital role in maintaining psychological well- being and significant implications for both physical and mental health. Research proves that by effectively recognizing, understanding and managing human emotions helps in overall well - being of the individuals extending its benefits to physiological process and normalization of pelvic and hormonal physiology. The study is focused on women with CPP from gynaecological disorders, due to amalgamation of emotions and hormonal changes that is clearly evident in monthly menstrual cycle of women. These disturbances show up as menstrual irregularities, severe premenstrual syndrome, leucorrhea and mood swings. An Individualized homoeopathic medicine based on totality of symptoms which include patient’s mental and physical sphere works holistically improving the mental sphere and improve physical signs and symptoms that are evident in homoeopathic cures. A Prospective, Nonrandomized, Open label, Single arm, Pre- Post Clinical Study with a sample size of 40 female chronic pelvic pain patients from gynaecological disorders satisfying inclusion and exclusion criteria shall be enrolled for the study. CPP patients suffering from gynaecological disorders who score 19 or below in cognitive reappraisal and 7 or above in expressive suppression in Emotion Regulation Questionnaire (ERQ) will be only enrolled for the study. The primary objective is to determine the changes in Difficulty in Emotion regulation Scale (DERS) at the baseline and after 6 months of intervention with Individualized homoeopathic medicine in suitable potency in accordance with the directions in Organon of Medicine (6th edition). Secondary objective is to determine the changes in intensity of pain in Functional Pelvic Pain Scale (FPPS) at the baseline and after 6 months of intervention. Ultrasound assessment of the abdomen and pelvis would be used as a secondary outcome tool for diagnosing gynaecological disorders. The descriptive data will be recorded in terms of absolute values, percentage etc. as appropriate. The score obtained by the patients will be compared and result analyzed as per appropriate statistical methods and inference will be done thereafter. The result will be published in scientific journals. |