| CTRI Number |
CTRI/2025/07/091321 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study effectiveness of Malyufal Modak in the management of Dysfunctional Uterine Bleeding |
|
Scientific Title of Study
|
Assessment of efficacy of Malayufal Modak in Raktapradar : Randomised 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 |
Shital Mahadev Gawali |
| Designation |
PG Scholar |
| Affiliation |
PMTs Ayurved College, shevgaon. |
| Address |
OPD no 113,PTSR department, shri eknath ayurved rugnalay, PMTs Ayurved college , shevgaon Tal-Shevgaon ,Dist -Ahmadnagar414502
MAHARATRA , INDIA
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
7559127724 |
| Fax |
|
| Email |
shitalgawali43@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Muttha |
| Designation |
Associate Professor |
| Affiliation |
PMTs Ayurved College, shevgaon. |
| Address |
OPD no 113,PTSR department, shri eknath ayurved rugnalay, PMTs Ayurved college , shevgaon Tal-Shevgaon ,Dist -Ahmadnagar414502
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9881807982 |
| Fax |
|
| Email |
dr.rahulmuttha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Muttha |
| Designation |
Associate Professor |
| Affiliation |
PMTs Ayurved College, shevgaon. |
| Address |
OPD no 113,PTSR department, shri eknath ayurved rugnalay, PMTs Ayurved college , shevgaon Tal-Shevgaon ,Dist -Ahmadnagar414502
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9881807982 |
| Fax |
|
| Email |
dr.rahulmuttha@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMTS Ayuved college Shevgaon Ahmadnagar |
|
|
Primary Sponsor
|
| Name |
PMTs Ayurved College, Shevgaon |
| Address |
OPD no 113,Prasutitantra and Streerog department, shri eknath ayurved rugnalay, PMTs Ayurved college , shevgaon Tal-Shevgaon ,Dist -Ahmadnagar414502
|
| 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 |
| Shital Mahadev Gawali |
PMTs Ayurved College, Shevgaon |
OPD no 113,PTSR department, shri eknath ayurved rugnalay, PMTs Ayurved college , shevgaon Tal-Shevgaon ,Dist -Ahmadnagar414502
Ahmadnagar
MAHARASHTRA |
07559127724
shitalgawali43@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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: Malayufal modak, Reference: Shartri L Yoga Ratnakar Uttrardh Streerogadhikar 15 varanasi chaukhamba prakashan 2015 :398, Route: Oral, Dosage Form: Modaka , Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhatki Pushpa, Reference: Bhavprakash Nighantu Adhyaya 1 /187, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Patient fulfilling diagnostic criteria-patient complaining of previous history of raktapradar for at least two consecutive cycle
2 Age group between 18 to 45
3 The duration of bleeding must be more than 7 days and quantity must be more than 3 pads per day per cycle |
|
| ExclusionCriteria |
| Details |
1 Patient suffering from severe anemia
2 know case of any pelvic pathology like tubo ovarian mass fibroids polyp malignant tumors endometriosis
3 know case of thyroid dysfunction hypertension TB DM
4 Patients with previously diagnosed bleeding disorders like hemophilia Von Willebrand disease
5.patients with IUCD OC pills |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of efficiency of Malayufal modak in Raktapradar |
5 days treatment with fallow up on 0,15,30,45,60,75,90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To review the disease of Raktapradar in details according to Ayurveda and Modern
2 To study efficacy of Dhataki pushpa churna in Raktapradar
3 To compare the efficacy of Malayufal modak and Dhataki pushpa churna in Raktapradar
4To observe any Adverse drug reaction |
5 days treatment with 6 fallow up on 0,15,30,45,60,75,90th day |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
28/07/2025 |
| 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="1"
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
|
The prevalence of DUB varies widely but an incidence is about 10% amongst new patient attending out patient. Various studies suggest that 30-50 % of women in the reproductive age group suffer from excessive and irregular uterine bleeding by different causative factors. 28% of the female population consider their menstruation bleeding excessive and will plan their social activities around their periods and 10% wf employed woman need to take time off work because of excessive bleeding.. Over 75000 Hystrectomies are now carried out every year. According to to modern science most frequent treatment used in Raktapradar is antifibrinolytic agents, hormonal therapy. But is has its limitations and contraindicated in certain conditions. And hence there is need for herbal drugs that can be used for all patients to overcome temporary phenomenon. Here Malayufal has been choosen for study due to its stambhak effect, tikta kashay rasa katu vipak sheet virya laghu and ruksha guna also pittha kaphashamak properties... The chemical composition found in malayufal is taking which act as an haemostatic medicine due to the astringent property.. This drug is easily available easy to take and cost effective.. |