| CTRI Number |
CTRI/2025/09/095232 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to check the role of an Indian drug Jonosia Asoka in improving pain in primary dysmenorrhoea in females of 15-45 years of age. |
|
Scientific Title of Study
|
Efficacy of Jonosia Asoka 6c in improving pain in primary dysmenorrhoea in reproductive age group a Double -Blind Randomized Placebo- Control Pilot 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 |
Shruti Debnath |
| Designation |
2nd BHMS Student |
| Affiliation |
Pratap Chandra Memorial Homoeopathic Hospital and College |
| Address |
OUT PATIENT DEPARTMENT (OPD)
Kolkata
WEST BENGAL
11
India |
| Phone |
8116496591 |
| Fax |
|
| Email |
shrutidebnath57@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Urmi Roy |
| Designation |
Assistant professor |
| Affiliation |
Pratap Chandra Memorial Homoeopathic Hospital and College |
| Address |
Out patient department(OPD)
Kolkata
WEST BENGAL
11
India |
| Phone |
98316 44467 |
| Fax |
|
| Email |
urmiroy58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Debnath |
| Designation |
2nd BHMS Student |
| Affiliation |
Pratap Chandra Memorial Homoeopathic Hospital and College |
| Address |
Out patient department (OPD)
Kolkata
WEST BENGAL
11
India |
| Phone |
8116496591 |
| Fax |
|
| Email |
shrutidebnath57@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pratap Chandra Memorial Homoeopathic Hospital and College. 14/1, Mahanambrata Sarani, Narkeldanga North Road, Kolkata 700011 |
|
|
Primary Sponsor
|
| Name |
Pratap Chandra Memorial Homoeopathic Hospital and College |
| Address |
14/1 Mahanambrata Sarani, Narkeldanga North Road Kolkata 700011 |
| Type of Sponsor |
Private 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 |
| Shruti Debnath |
Pratap Chandra Memorial Homoeopathic Hospital and College |
Out patient department (OPD)
Kolkata
WEST BENGAL |
81164 96591
shrutidebnath57@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
Jonosia Asoka 6C |
4 doses a day at an interval of 6 hours for first 2 days of menstruation.Each dose will consist of 4 cane sugar globules no. 40 moistened with Jonosia Asoka 6C, to be taken orally on clean tongue. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Placebo |
4 doses a day at an interval of 6 hours for first 2 days of menstruation.Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients age 15-45 years suffering from primary dysmenorrhoea with pain score of 4-9 on numeric rating scale. Females willing to provide a written informed consent or assent forms voluntarily. |
|
| ExclusionCriteria |
| Details |
Patients having any abnormal pelvic pathology in USG of lower abdomen, undergoing any hormone replacement therapy, using contraceptive pills or history of using it in previous 3 months, using NSAIDS in regular basis, under any addiction of alcohol,tobacco and/or any other form of substance abuse, already undergoing homoeopathic or any system of treatment within last 6 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To detect the change in pain score by Numeric Rating Scale on day 1 and 2 of menstruation during 3 months of intervention by Jonosia Asoka 6C and placebo in treatment of primary dysmenorrhoea. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To detect the change in Dysmenorrhoea Symptom Interference Scale scores during 3 months of intervention by Jonosia Asoka 6C and placebo in treatment of primary dysmenorrhoea. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
06/10/2025 |
| 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="0"
Months="6"
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
|
This is a double blind, randomized, placebo controlled pilot trial where we will assess the efficacy of Jonosia Asoka 6C in reducing pain in primary dysmenorrhoea by using Numeric Rating Scale(NRS) and changes in other outcomes of primary dysmenorrhoea will be accessed using Dysmenorrhoea Symptom Interference(DSI) scale. |