| CTRI Number |
CTRI/2026/01/101254 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Add on effect of Alabu Modaka in women with heavy menstrual bleeding |
|
Scientific Title of Study
|
Efficacy of Alabu Modaka as an add on to Bolabaddha rasa in Menorrhagia hypen A Randomized 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 Prathiba B |
| Designation |
PG scholar |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Swasthavritta
VPSV Ayurveda College Kottakkal
Department of Swasthavritta
VPSV Ayurveda College Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
7358639215 |
| Fax |
|
| Email |
preetkrish1598@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M C Shobhana |
| Designation |
Professor and HOD |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Swasthavritta
VPSV Ayurveda College Kottakkal
Department of Swasthavritta
VPSV Ayurveda College Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
9446321535 |
| Fax |
|
| Email |
drshobhamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M C Shobhana |
| Designation |
Professor and HOD |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Swasthavritta
VPSV Ayurveda College Kottakkal
Department of Swasthavritta
VPSV Ayurveda College Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
9446321535 |
| Fax |
|
| Email |
drshobhamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| VPSV Ayurveda college kottakkal |
|
|
Primary Sponsor
|
| Name |
VPSV Ayurveda college kottakkal |
| Address |
VPSV Ayurveda college kottakkal Edarikode P O kottakkal Malappuram district Kerala 676501 |
| Type of Sponsor |
Other [Aided 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 |
| Dr Prathiba B |
VPSV Ayurveda College Hospital kottakkal |
OPD Department of Prasuti Tantra and Stree roga Room no A202
Malappuram
KERALA
Malappuram
KERALA |
7358639215
preetkrish1598@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee [IEC] Vaidyaratnam P S Varier Ayurveda College Kottakkal |
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. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Alabu modaka, Reference: Bhavaprakasha, Route: Oral, Dosage Form: Modaka , Dose: 12(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: 2 consecutive menstrual cycles | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bolabaddha rasa, Reference: Bharata Bhaisajya Ratnakarara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Honey), Additional Information: 2 consecutive menstrual cycles |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Prolonged menstrual bleeding of more than 7 days and or or excessive menstrual bleeding
with PBAC score greater than 100
2. Participant with Hb greater than 8 g%
3. Participants diagnosed with fibroid uterus
4. Willingness to provide informed written consent |
|
| ExclusionCriteria |
| Details |
1. Participants with intermenstrual bleeding
2. Bleeding associated with OCP and IUCD
3. Participants diagnosed with any form of malignancy
4. Participants on prolonged medication for systemic illnesses like thyroid dysfunction,
diabetes mellitus, severe hypertension, liver cirrhosis, congestive cardiac failure
5. Participants who have received hormonal therapy within the past 3 months
6. Participants with known coagulation disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the PBAC scores |
1st assessment: On the day of 1st OPD visit
2nd assessment: After the bleeding phase of 1st cycle
3rd assessment: After the bleeding phase of 2nd cycle
4th assessment: After the bleeding phase of 3rd cycle
Follow-up: After the bleeding phase of 4th cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menstrual bleeding questionnaire for quality of life assessment |
1st assessment: On the day of 1st OPD visit
2nd assessment: After the bleeding phase of 1st cycle
3rd assessment: After the bleeding phase of 2nd cycle
4th assessment: After the bleeding phase of 3rd cycle
Follow-up: After the bleeding phase of 4th cycle |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
21/01/2026 |
| 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
|
A Randomized controlled trial is planned to assess the additional effect of Alabu Modaka along with Bolabaddha rasa against Bolabaddha rasa alone. Participants who satisfy the inclusion criteria will be randomly allocated in two groups Group 1 and Group 2 by simple random sampling using computer generated random numbers. In the Group 1, Alabu Modaka along with Bolabaddha rasa will be given and in the Group 2, Bolabaddha rasa will be given. Assessment will be conducted during the first OPD visit and after each bleeding phase of the 1st, 2nd, and 3rd cycles and follow up will be done after the bleeding phase of 4th cycle using PBAC scores. Quality of life will be assessed using the Menstrual Bleeding Questionnaire. Data will be compiled and statistically analysed to draw conclusion. |