CTRI Number |
CTRI/2023/11/060229 [Registered on: 24/11/2023] Trial Registered Prospectively |
Last Modified On: |
17/12/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Homeopathy |
Study Design |
Other |
Public Title of Study
|
Homoeopathy in the treatment of dysmenorrhea in adolescents |
Scientific Title of Study
|
Efficacy of individualized homoeopathy in treatment of primary dysmenorrhea in adolescents:a randomized, double blind, placebo-controlled trial. |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Varanasi Roja |
Designation |
Research Officer (Homoeopathy), Scientist-3 |
Affiliation |
Central Council for Research in Homoeopathy |
Address |
Room No. 315, Central Council for Research in Homoeopathy,
61-65,Institutional Area, Opp. D Block, Janakpuri, New Delhi.
South West DELHI 110058 India |
Phone |
9999454036 |
Fax |
|
Email |
varanasiroja@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shweta Gautam |
Designation |
Research Officer (Homoeopathy), Scientist-1 |
Affiliation |
Dr D P Rastogi Central Research Institute for Homoeopathy |
Address |
Room No. 226, A-1/1, Sector-24, Noida
Gautam Buddha Nagar UTTAR PRADESH 201301 India |
Phone |
9999566890 |
Fax |
|
Email |
dr.shwetagtm@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Varanasi Roja |
Designation |
Research Officer (Homoeopathy), Scientist-3 |
Affiliation |
Central Council for Research in Homoeopathy |
Address |
Room No. 315, Central Council for Research in Homoeopathy,
61-65,Institutional Area, Opp. D Block, Janakpuri, New Delhi.
South West DELHI 110058 India |
Phone |
9999454036 |
Fax |
|
Email |
varanasiroja@gmail.com |
|
Source of Monetary or Material Support
|
Central Council for Research in Homoeopathy,
61-65,Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058. |
|
Primary Sponsor
|
Name |
Central Council for Research in Homoeopathy |
Address |
Central Council for Research in Homoeopathy,
61-65,Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058. |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 3 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Lipipushpa Debata |
Central Research Institute (Homoeopathy) |
Room No. 217, Central Research Institute for Homoeopathy,
Sector 2, Jankipuram Extension, Near Uithouli crossing Lucknow-226010
Uttar Pradesh Lucknow UTTAR PRADESH |
8929031218
drlipi08@gmail.com |
Dr Shweta Gautam |
Dr D P Rastogi, Central Research Institute (Homoeopathy) |
Room No. 226, A-1/1, Sector 24,Noida, Uttar Pradesh-201301. Gautam Buddha Nagar UTTAR PRADESH |
9999566890
dr.shwetagtm@gmail.com |
Dr P Hima Bindu |
Regional Research Institute (Homoeopathy) |
Room No.1,Regional Research Institute(H), OUB-32, Street no. 4, Vikram Puri, Habsiguda, Hyderabad-500007
Telangana Hyderabad TELANGANA |
9490009899
drdewdrop@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Central Ethics Committee, Central Council for Research in Homoeopathy |
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 |
Comparator Agent |
Identical placebo |
unmedicated sugar pills |
Intervention |
Individualized homoeopathic medicines |
Known homoeopathic pharmacopoeial preparations in different potencies. |
|
Inclusion Criteria
|
Age From |
13.00 Year(s) |
Age To |
19.00 Year(s) |
Gender |
Female |
Details |
1.Patients conformed to the diagnostic criterion of Primary Dysmenorrhoea according to the Primary Dysmenorrhea Consensus Guidelines and if they had experienced primary dysmenorrhoea for two or more months.
2.Age between 13 to 19 years.
3.Menstrual cycle(21 to 35) days.
4.Pain on numeric rating scale (NRS)>4.
5.Signed informed consent of the parent and assent of the children.
|
|
ExclusionCriteria |
Details |
1.Secondary dysmenorrhea caused by endometriosis, uterine myoma, endometrial polyps, pelvic inflammatory disease, or other gynecological problems confirmed by a gynecological, abdominal ultrasound examination.
2.Females with irregular/infrequent menstrual cycles (outside of the typical range 21 to 35 day’s cycle)
3.Patients with haemoglobin less than 7gm/dl.
4.Patients complicated with severe diseases (e.g. cerebral, liver, kidney, systemic diseases, mental disorders)
5.Received other alternative therapies such as massage, acupressure, herbal therapy in the previous one month.
6.Those who have been treated with hormone drugs over the last 3 months.
7.poor treatment compliance (e.g. unstable working and living situation, difficult follow-up).
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pharmacy-controlled Randomization |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
Number of pain days in Homoeopathic group as compared to placebo group over 6 months. |
At baseline and then every month over 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate the change in intensity of pain of dysmenorrhea on numeric rating scale over 6 months. |
At baseline and then every month over 6 months |
To evaluate the reduction in consumption of analgesics over 6 months. |
At baseline and then every month over 6 months |
To evaluate the changes in working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score over 6 months. |
At baseline and then every month over 6 months |
To evaluate the changes in mean number of reporting absenteeism days from school/work over 6 months. |
At baseline and then every month over 6 months |
To evaluate the changes in scores of Menstrual distress questionnaire (MDQ) at 3rd and 6th month. |
At baseline, 3rd and 6th month. |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
01/12/2023 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
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
|
Dysmenorrhea is one of the most common gynaecological problems and is characterized by acute pelvic pain during menstruation. Primary dysmenorrhea is the presence of painful menstruation in the absence of pelvic diseases (e.g., endometriosis and pelvic inflammatory disease) or pelvic leiomyoma. Primary dysmenorrhea is the most common form of chronic pelvic pain that can last for at least 6 months, can be severe enough to disrupt one’s daily life activities, and ultimately lead to medical or surgical treatment. The reported prevalence of dysmenorrhea has ranged from 15.8% to 89.5%, with higher rates reported in adolescent populations. It is the leading women hood problem that affects 90% of adolescent girls and more than 50% menstruating women. Prior studies have shown the impact of dysmenorrhea on quality of life as dysmenorrhea often leads to women not attending school or office. The rate of absence days from school was reported to vary between 14% and 51% among women with dysmenorrhea. The conventional treatment for primary dysmenorrhea is Nonsteroidal anti-inflammatory medications (NSAIDs) and oral contraceptives, but it has lot of side effects. As a result, patients seek complementary and alternative therapies, such as Homoeopathy as a treatment option for Primary dysmenorrhea and in Homoeopathic literature, myriads of drugs have been mentioned for Primary dysmenorrhea. This research study is planned to be carried out to obtain scientific evidence of the effectiveness of homeopathy in in reducing the pain days in Primary Dysmenorrhea in adolescents with an added benefit of knowing the efficacy of homoeopathy in reducing the use of analgesics for dysmenorrhea as well as improving the sick days or days of absenteeism in a student life. |