| CTRI Number |
CTRI/2025/01/079248 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Chandrakalarasa in excessive menstrual bleeding |
|
Scientific Title of Study
|
Effect of Chandrakalarasa in Abnormal Uterine Bleeding due to Ovulatory Dysfunction |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maya S Kumar |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of Prasuti Tantra and Streeroga,Government Ayurveda College Tripunithura Ernakulam,Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9747180719 |
| Fax |
|
| Email |
myasuresh7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahina Mole S |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of Prasuti Tantra and Streeroga ,Government Ayurveda College Tripunithura Ernakulam ,Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shahina Mole S |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of Prasuti Tantra and Streeroga ,Government Ayurveda College Tripunithura Ernakulam ,Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Tripunithura,Ernakulam,Kerala,India 682301 |
|
|
Primary Sponsor
|
| Name |
Maya S Kumar |
| Address |
PG Scholar,Department of PrasutiTantra and Streeroga,Government Ayurveda College,Tripunithura,Ernakulam,Kerala 682301 |
| 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 Maya S Kumar |
Government Ayurveda College Tripunithura |
Department of prasutitantra striroga,ground floor,hospital building ,682301
Ernakulam
KERALA |
9747180719
myasuresh7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee for Ethics in Research[Institutional Review Board],Govt Ayurveda College Tripunithura ,Kochi,Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N939||Abnormal uterine and vaginal bleeding, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chandrakalarasa, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Medication will be given for a period of maximum 10 days or till stoppage of bleeding for 3 consecutive menstrual cycle |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women who are willing to give written consent among the age group of 18 to 45 years having the complaint of ovulatory dysfunction by excluding other structural and functional causes of AUB by USG abdomen and pelvis, prolonged bleeding that is for a period of more than 7 days and excessive menstrual bleeding for blood loss of more than 80 ml or changing more than 3 pads completely soaked per day for the past 3 menstrual cycle |
|
| ExclusionCriteria |
| Details |
Blood haemoglobin level less than 7gm percentage, pregnant and lactating mothers,vaginal bleeding due to inherited bleeding disorders,vaginal bleeding after menopause,bleeding in patients taking hormonal therapy,associated with IUCD or oral contraceptive pills,known case of systemic diseases like uncontrolled diabetic mellitus,hypertension,liver dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Chandrakala rasa in reducing the amount of bleeding in AUB O assessed by PBAC score and in reducing duration of bleeding |
after 3 consecutive menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the effect of Chandrakala rasa on blood haemoglobin level |
after 3 consecutive menstrual cycles |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/02/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - pdf files
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Abnormal uterine bleeding is a condition where there is deviations from normal terms of
volume, duration, regularity, or frequency of uterine bleeding, constituting nearly 30% of all
gynecological complaints. In 2011, FIGO introduced PALM-COEIN classification system to
categorize the etiological factors of abnormal uterine bleeding.Among the various etiological
factors outlined in this classification, ovulatory dysfunction is a significant contributor to
abnormal uterine bleeding.In Ayurveda a similar condition is seen, named “Asrigdhara”
characterized by excessive or prolonged vaginal bleeding.The treatment principles of
rakthapitta,raktha atisara,raktha arshas,guhyaroga and garbhasrava can be adopted.
This study focuses on investigating the effect of Chandrakala rasa, a herbomineral formulation
indicated for managing "rakthapitta" and "pradara,"in AUB-O. Chandrakala rasa, mentioned
in the "mutrakricha prakarana" of Bhaisajya Ratnavali, contains ingredients which are mainly
vatapittasamana,that helps in addressing abnormal uterine bleeding.
The study design is an Interventional pre- and post study ,with sample size 26 including
subjects aged 18-45 years diagnosed with abnormal uterine bleeding due to ovulatory
dysfunction, coming under specific inclusion and exclusion criteria. Data collection will be
done by clinical observation through case proforma and relevant investigations. Medicines are
sourced from GMP-certified pharmacy and administered in a prescribed manner.The medicine
is prescribed in the following manner, that is 250mg of Chandrakala rasa will be given twice
daily after food, starting from the fourth day of menstrual bleeding until cessation of bleeding
or for a period of maximum 10 days. The duration of the clinical trial will be 3 consecutive
menstrual cycle. Assessment will be done on the basis of Pictorial Blood loss Assessment Chart
score after each bleeding phase when bleeding stops or 5th day or 10th day of medication .
Vitals will be checked on each visit. The results will be analysed statistically with appropriate
tests and the conclusions will be derived. |