| CTRI Number |
CTRI/2024/10/075895 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study To See Effect Of Malayufal modak and
Nagkeshar churna in 60 Women Patient Having Menorrhagia That Is Heavy Or Prolonged Menstrual Bleeding |
|
Scientific Title of Study
|
An Open Randomized Comparative clinical study of Malayufal modak(Yogratnakar)and
Nagkeshar churna(Shodhal)in the management of Asrugdara with special reference to
Menorrhagia |
| 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 Rupali manohar Kamble |
| Designation |
post graduate students |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
APMs Ayurved Mahavidyalaya sion near sion railway station sion
Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8169932042 |
| Fax |
|
| Email |
rupalikamble9967714599@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata shrikant jagtap |
| Designation |
Associate Professor and HOD |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
APMs Ayurved Mahavidyalaya sion near sion railway station sion
Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9820556568 |
| Fax |
|
| Email |
sujatashrikantjagtap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata shrikant jagtap |
| Designation |
Associate Professor and HOD |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
APMs Ayurved Mahavidyalaya sion near sion railway station sion
Mumbai 400022
MAHARASHTRA
400022
India |
| Phone |
9820556568 |
| Fax |
|
| Email |
sujatashrikantjagtap@gmail.com |
|
|
Source of Monetary or Material Support
|
| APMs Ayurved Mahavidyalaya Sion near sion railway station sion east mumbai 400022 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Rupali manohar kamble |
| Address |
APMs Ayurved Mahavidyalaya sion near sion railway station sion
Mumbai 400022 |
| 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 Rupali Manohar kamble |
APMs Seth R V Ayurved Hospital |
OPD No 8 Department of prasuti tantra evum stree roga 3rd floor APMs Ayurved
Mahavidyalaya and
Seth R V Ayurved
Hospital near Sion
railway station Sion east
Mumbai 400022
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
8169932042
rupalikamble9967714599@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya Sion IEC |
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: Malayufal Modak , Reference: Yogratnakar Pradar Chikitsa Adhaya Sholka No 15, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Swangsheet jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nagkeshar Churna, Reference: Bhavprakash Karpooradi varga sholka No 70/71, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Swangsheet jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients between age group of 18yrs to 45yrs
2. Patients having Haemoglobin more than 9gm%.
3. Patients mainly complaining of cardinal symptoms of Asrugdara (i.e. Ati rajastrava,
atyadhik rajakalavadhi , Adhoudarshoola, Anaritukaal) for at least 2 consecutive
cycles.
4. Patient ready to participate in study with proper written consent |
|
| ExclusionCriteria |
| Details |
1. Patients having malignant or benign tumour, fibroid, polyp, tubo ovarian mass,
endometriosis, adenomyosis etc.
2. Patients having systemic diseases K/C/O.- Hypertension, Diabetes Mellitus,
Endocrinal disorder.
3. Patients with IUCD or on OC pills or on Hormonal treatment.
4. Patients having gross abnormalities of uterus and pelvis.
5. Post-delivery, post MTP, post D & C bleeding.
6. Patient age below 18 year and above 45 year.
7. Bleeding disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pictorial Blood loss assessment chart
Hb(Before treatment)
USG Abdomen and Pelvis
BT CT (if necessary)
Thyroid Function Test (if necessary) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Raja Atipravruthi
2. Deerghakalanubandhi
3. Anaritukaal(intermenstrual bleeding)
4. Along with or without Angamarda and vedana or Adhodarshoola. |
1 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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 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 - NO
|
|
Brief Summary
|
Now a days due to unhealthy lifestyles, mental stress, Asrugdara disease increasing day by day in reproductive age group female.Causes serious illness like general weakness, anemia etc. In modern science, various therapeutic options given i.e., medical (Hormonal and/or antifibrinolytics, anti-prostaglandins) and surgical (D & C, Endometrial ablation, hysterectomy) but no treatment is free of side effects. In today’s world to maintain mental, physical health of women,need to solve this emerging problem. So keeping all above ideas in mind Malayufal modak is selected to evaluate and establish safe, cost effective, Ayurvedic treatment in management of Asrugdara .Negligence in treatment causes anemia, weakness/giddiness, mental confusion, delirium, drowsiness, dizziness, thirst, dysponea, burning sensation,death. |