| CTRI Number |
CTRI/2025/07/091980 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate clinically the efficacy of Xanthoxylum Fraxineum in management of primary dysmenorrhea an analytical study |
|
Scientific Title of Study
|
To evaluate clinically the efficacy of xanthoxylum franieum in management of primary dysmenorrhea an analytical 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 |
Resham Rana |
| Designation |
Post Graduate Resident |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre
10 A Institutional Area sitapura Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9548310240 |
| Fax |
|
| Email |
reshamrana1601@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanuj Rajvanshy |
| Designation |
Vice Principal |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
Jawahar Nagar Jaipur Rajasthan
Swasthya Kalyan Homoeopathic Medical College and Research Centre
10 A Institutional Area sitapura Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829051148 |
| Fax |
|
| Email |
drtanujrajvanshy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanuj Rajvanshy |
| Designation |
Vice Principal |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
Jawahar Nagar Jaipur Rajasthan
Swasthya Kalyan Homoeopathic Medical College and Research Centre
10 A Institutional Area sitapura Jaipur
RAJASTHAN
302004
India |
| Phone |
9829051148 |
| Fax |
|
| Email |
drtanujrajvanshy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic Medical College & Research Centre
10-A, Sitapura Institutional Area, Tonk Road, Goner Road, Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan 302022 |
|
|
Primary Sponsor
|
| Name |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre
10 A instutional area sitapura jaipur rajasthan 302022 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Resham Rana |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
10 A Sitapura Institutional Area Tonk Road Goner Road Sitapura Industrial Area Sitapura Jaipur Rajasthan 302022
obs and gyne room number 33
Jaipur
RAJASTHAN |
09548310240
reshamrana1601@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHKMCIEC |
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 |
Homoeopathic medicine |
4 pills, pills number 30, Route of administration - oral,Doses and frequency as per the requirement of the case. for 3 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed cases of Primary Dysmenorrhea and patient having complaint of Primary Dysmenorrhea.
Females of reproductive age group
|
|
| ExclusionCriteria |
| Details |
Females having other chronic condition which is not related to Primary Dysmenorrhea.
Females outside fertile periods.
Females having autoimmune disease. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment done on pre and post score by using WaLIDD scale and regular follow-up |
Assessment done on pre and post score by using WaLIDD scale and regular follow-up . after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To formulate the homoeopathic remedy profile for management of Primary Dysmenorrhea. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
10/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study ia a interventional and single arm study to see the clinically efficacy of xanthoxylum fraxineum in management of primary dysmenorrhea . The study will be conducted at Swasthya Kalyan Homoeopathic Medical College And Research Centre, Jaipur. The primary outcome measures on the basis of pre and post score by using WaLIDD scale , regular follow-up assessment . It will be conducted for 1 year. The objectives are to determine the efficacy of xanthoxylum fraxineum in management of Primary Dysmenorrhea by using WaLIDD Scale and to determine any additional clinical symptoms cured by Xanthoxylum fraxineum. |