| CTRI Number |
CTRI/2022/10/046447 [Registered on: 13/10/2022] Trial Registered Prospectively |
| Last Modified On: |
06/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Studying the action of individualized homoeopathic medicine on QOL of patients suffering from primary Dysmenorrhoea |
|
Scientific Title of Study
|
Studying the action of individualized (indicated and constitutional) homoeopathic medicine on QOL of patients suffering from primary dysmenorrhoea of age group 13 - 35 years by using WaLIDD scale to evolve indications of homoeopathic remedies of dysmenorrhoea - An experimental - Randomized Control Trial |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailja Dilip Nandha |
| Designation |
Ph. D Research Scholar |
| Affiliation |
Smt Malini kishore Sanghvi Homoeopathic college and hospital |
| Address |
Room NO 19 1st Floor Department of Obstetrics and Gynaecology Smt MKSH college and hopsital Opposite Sumeru Navkar Tirth Amod Road Karjan District Vadodara
Vadodara
GUJARAT
391240
India |
| Phone |
9376939651 |
| Fax |
|
| Email |
drshailja16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hitesh G Purohit |
| Designation |
Professor and guide |
| Affiliation |
Smt MKSH college and hospital |
| Address |
Room NO 9 1st Floor Department of Materia Medica Smt MKSH college and hopsital Opposite Sumeru Navkar Tirth Amod Road Karjan District Vadodara
Vadodara
GUJARAT
391240
India |
| Phone |
9825592130 |
| Fax |
|
| Email |
drhiteshp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailja Dilip Nandha |
| Designation |
Ph. D Research Scholar |
| Affiliation |
Smt Malini Kishore Sanghvi Homoeopathic college and hospital |
| Address |
Room NO 19 1st Floor Department of Obstetrics and Gynaecology Smt MKSH college and hopsital Opposite Sumeru Navkar Tirth Amod Road Karjan District Vadodara
Vadodara
GUJARAT
391240
India |
| Phone |
9376939651 |
| Fax |
|
| Email |
drshailja16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Shailja Dilip Nandha
Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Shailja Dilip Nandha |
| Address |
A 201 Anandvilla Flats Opposite Dwarkesh Party Plot Vasna Road Vadodara 390007 Gujarat |
| Type of Sponsor |
Other [Ph D Study] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital |
Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital Opposite Sumeru Navkar Tirth Miagam Amod Road Miagam Karjan 391240 Vadodara Gujarat |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailja Dilip Nandha |
Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital |
Room NO 19 1st Floor Department of Obstetrics and Gynaecology Opposite Sumeru Navkar Tirth Amod Road Karjan
Vadodara
GUJARAT |
9376939651
drshailja16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine
|
Individualized Homoeopathic
Medicine Doses 30 to 10 M
Repetition as per Homoeopathic
principles
Route of administration
orally
Duration of treatment 9 months |
| Comparator Agent |
Placebo |
Homoeopathic placebo
Route of administration orally
Duration of treatment 9 months |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Female of age 13 years to 35 years
Female diagnosed of suffering from Primary Dysmenorrhoea |
|
| ExclusionCriteria |
| Details |
Female suffering from Dysmenorrhoea due to any pathology in pelvic organs |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the changes in the pattern of cyclic expressions during menses after giving individualized constitutional medicine every month by Walidd scale till 9 months
To evaluate action of individualized constitutional medicine in improving QOL of patients suffering from primary dysmenorrhea every 3 months by SF 36 scale till 9 months
To assess the action of indicated homoeopathic medicine in relief of pain during each cycle with the help of Walidd scale till 9 months
To evolve indications of various homoeopathic medicines of Dysmenorrhoea by clinical verification with the help of LSMC
|
To assess the changes in the pattern of cyclic expressions during menses after giving individualized constitutional medicine every month by Walidd scale till 9 months
To evaluate action of individualized constitutional medicine in improving QOL of patients suffering from primary dysmenorrhea every 3 months by SF 36 scale till 9 months
To assess the action of indicated homoeopathic medicine in relief of pain during each cycle with the help of Walidd scale till 9 months
To evolve indications of various homoeopathic medicines of Dysmenorrhoea by clinical verification with the help of LSMC
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study likelihood ratio of three prominent symptoms of dysmenorrhea of frequently prescribed homoeopathic medicines by clinical verification
To study relationship of acute complimenting chronic medicine with the help of EET
To establish the association of positive family history in first degree relative suffering from primary dysmenorrhea
To establish the association of mental stress as a precipitating or maintaining cause of Dysmenorrhoea
|
Three years |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No Publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an experimental randomized control study The primary objective is to assess the changes in the pattern of cyclic expression during menses after giving individualized constitutional medicine every month by Walidd scale till 9 months. To evaluate action of individualized constitutional medicine in improving QOL of patients suffering from primary dysmenorrhea every 3 months by SF -36 scale till 9 months To assess the action of indicated homoeopathic medicine in relief of pain during each cycle with the help of Walidd scale till 9 months. To evolve indications of various homoeopathic medicines of Dysmenorrhoea by clinical verification with the help of LSMC
The secondary objectives are To study likelihood ratio of three prominent symptoms of dysmenorrhea of frequently prescribed homoeopathic medicines by clinical verification. To study relationship of acute complimenting chronic medicine with the help of EET. To establish the association of positive family history in first degree relative suffering from primary dysmenorrhea. To establish the association of mental stress as a precipitating or maintaining cause of Dysmenorrhoea |