| CTRI Number |
CTRI/2025/12/098592 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Crocus Sativus in prouse menstrual bleeding |
|
Scientific Title of Study
|
Role of Crocus Sativus in cases of Menorrhagia in age group between 15-30 years assessed by PBAC Score - Prospective single group experimental 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 |
Dr Keyaben Patel |
| Designation |
PG Scholar |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute |
| Address |
Room no 8 Department of gynecology and obstetrics Ground floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali building Near district session court Mahesana Gujarat
Mahesana
GUJARAT
384001
India |
| Phone |
9016863841 |
| Fax |
|
| Email |
keya4798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Trivedi |
| Designation |
Professor of PG Department of Homoeopathic Materia Medica |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research |
| Address |
PG Department of Homoeopathic Materia Medica Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali building Near district session court Mahesana Gujarat
Mahesana
GUJARAT
384001
India |
| Phone |
9974342824 |
| Fax |
|
| Email |
nisha.mehul.26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Keyaben Patel |
| Designation |
PG Scholar |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute |
| Address |
Room no 8 Department of gynecology and obstetrics Ground floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali building Near district session court Mahesana Gujarat
Mahesana
GUJARAT
384001
India |
| Phone |
9016863841 |
| Fax |
|
| Email |
keya4798@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali building Near district session court Mahesana Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Keyaben Patel |
| Address |
Room no.8 Department of Gynecology and obstetrics Ground floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali building Near district session court Mahesana Gujarat 384001 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Keyaben Patel |
Smt A J Savla Homomeopathic Medical College and Research Institute |
Room no 8 Department of gynecology and obstetrics Ground floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali building Near district session court Mahesana Gujarat 384001
Mahesana
GUJARAT |
9016863841
keya4798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt A J Savla Homoeopathic Medical College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Crocus Sativus |
Potency Decimal Centesimal
50 Millesimal Doses as per
need of cases Crocus Sativus Homoeopathic Medicine will be dispensed as per the potency Frequency as per need of cases Route of administration Oral Duration of therapy upto 8 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed cases of menorrhagia are included in the study
Patient should be selected on the basis of ICD 11 code of menorrhagia GA20.50 as mentioned in review of literature
Consent – participants are willing to provide written informed consent to participate in the study and can fill out the pictorial blood assessment chart-PABC to be include in study
A case showing symptoms similarity with the Crocus Sativus
Patient having Hb level 8 or more than 8 mg/ dl is included for the study
Patient having PBAC Scale 100 or more than 100 are considered |
|
| ExclusionCriteria |
| Details |
Patient who is suffering from any kind of structural abnormality
Patient who is on hormonal therapy
Patient with other systemic disease like endocrinal hematological etc
Patients who are on allopathic ayurvedic and homeopathic system of medicine |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By using PBAC - Pictorial Blood Assessment Chart Score |
The PBAC Score will be assessed at the baseline and the end of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
16/12/2025 |
| 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="6"
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 is prospective pre-test post-test single group experimental study to assess the role of Crocus Sativus in cases of Menorrhagia in age group between 15-30 years for 8 months in 30 participants with Menorrhagia selected according to inclusion and exclusion criteria from Outpatient Department and the outcome will assess the reduction in PBAC Score by PBAC Scale assessed at baseline and at the end of treatment |