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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
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