| CTRI Number |
CTRI/2023/04/051900 [Registered on: 24/04/2023] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs,vati of rasanjan,laksha and aja ksheera and tablet progesterone in patients with heavy menstrual bleeding |
|
Scientific Title of Study
|
A randomised controlled clinical study to compare efficacy of vati of rasanjan,laksha and aja ksheera in comparison with tablet progesterone in the management of asrugdar(menorrhagia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Baliram Mutkule |
| Designation |
Bams PG scholar Streerog and Prasutitantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
OPD No.11, Streerog and Prasutitantra Department, Ground floor,Tarachand Hospital,Rasta Peth,Pune
Tarachand Hospital,IPD Building, PG girls hostel,Nanal Street,Rasta Peth,Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8766694989 |
| Fax |
|
| Email |
mutkulepriyanka22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul J Garudkar |
| Designation |
Associate Professor Streerog and Prasutitantra Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Streerog and Prasutitantra Department,Tarachand Hospital,Rasta Peth,Pune
Tarachand Hospital Nanal Street Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822777367 |
| Fax |
|
| Email |
drrahulgarudkar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul J Garudkar |
| Designation |
Associate Professor Streerog and Prasutitantra Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Streerog and Prasutitantra Department,Tarachand Hospital Rasta Peth Pune
Tarachand Hospital Nanal Street Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822777367 |
| Fax |
|
| Email |
drrahulgarudkar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurved Hospital,Rasta Peth,Pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
OPD No.11,Streerog and Prasutitantra Department,Tarachand Hospital,Nanal Street,Rasta Peth,Pune |
| 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 |
| Priyanka Baliram Mutkule |
Seth Tarachand Ramnath Charitable Ayurved Hospital |
OPD No.11, Streerog and Prasutitantra Department,Ground floor,Rasta Peth,Pune
Pune
MAHARASHTRA |
8766694989
mutkulepriyanka22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seth Tarachand Ramnath Charitable Ayurved Hospital ec |
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: Vati of Rasanjan,Laksha and Aja Ksheera , Reference: Charak Chikitsasthan 30/97, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -Number of patients- 28
Drug- Vati of Rasanjan, Laksha and Aja ksheera
Duration of study-3 months
Route of administration - Orally
Dose -500 mg bd.
Sevanakal- Two times a day after meal | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet progesterone | Group 2- Control group,Number of patients-28,Drug- Tablet Progesterone 5mg 1 OD for 3months,Route of administration- orally,During course of treatment detailed observations
and records will be taken and follow up after 15 days for 3 months |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1 age group- 25-50 years
2 Increased number of bleeding days i.e more than 7days
3 Quantitave increase in menstrual blood i.e more than 80ml or more than 3 pads per day
4 Decreased intermenstrual period i.e lessthan 21 days
5 Fibroid uterus |
|
| ExclusionCriteria |
| Details |
1 Traumatic bleeding
2 Post-menopausal bleeding
3 Cervical, uterine, ovarianneoplasm
4 Coagulopathy
5 Endometriosis
6 Bleeding through gravid uterus
7 Cervical polyp
8 Cervical erosion
9 Hyertensive Disorders, DM, Bleeding disorders, Cardiac diseases
10 Severe anemia( Hb < 8gm%)
11 HIV,HbsAg,VDRL,HPV positive
12 Congenital anomalies of genital tract
13 Patient requiring emergency management |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To assess decrease in number of menstrual bleeding days
2 To assess quantitave decrease in menstrual bleeding
3 To assess relief in Katishool(lower abdominal pain)
4 Artavgrahitatwa(consistency presence of clots in menstrual blood) |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2023 |
| Date of Study Completion (India) |
31/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised controlled clinical study to compare efficacy of vati of rasanjan,laksha and aja ksheera 500mg BD daily in comparison with tablet progesterone 5mg 1OD daily in the management of asrugdar(menorrhagia).Total number of patients is 56. |