| CTRI Number |
CTRI/2025/04/084683 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the efficacy of Ashokavalkalaksheerpaka in the management of Asrigdara |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Ashokavalkalaksheerpaka in the management of Asrigdara |
| 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 Neelam kumari |
| Designation |
Post graduate scholar |
| Affiliation |
Government Ayurvedic College Kadamkuan Patna |
| Address |
Department of Prasuti tantra evum stri roga, Government Ayurvedic college and hospital Kadamkuan Budhamurti Kadamkuan Patna 800003
Patna
BIHAR
800003
India |
| Phone |
8340648427 |
| Fax |
|
| Email |
dr.neelamkumari05071995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabha kumari |
| Designation |
Associate professor and Head of department prasuti tantra evum stri roga |
| Affiliation |
Government Ayurvedic College Kadamkuan Patna |
| Address |
Department of Prasuti tantra evum stri roga, Government Ayurvedic college and hospital Kadamkuan Budhamurti Kadamkuan Patna 800003
Patna
BIHAR
800003
India |
| Phone |
7004860634 |
| Fax |
|
| Email |
dr.prabhapandey@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelam kumari |
| Designation |
Post graduate scholar |
| Affiliation |
Government Ayurvedic College Kadamkuan Patna |
| Address |
Department of Prasuti tantra evum stri roga, Government Ayurvedic college and hospital Kadamkuan Budhamurti Kadamkuan Patna 800003
Patna
BIHAR
800003
India |
| Phone |
8340648427 |
| Fax |
|
| Email |
dr.neelamkumari05071995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital Kadamkuan Budhamurti Patna Bihar India Pin code 800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic college and hospital Kadamkuan Budhamurti patna |
| Address |
Government Ayurvedic college and hospital Kadamkuan Budhamurti patna 800003 |
| Type of Sponsor |
Other [Government Ayurvedic college and hospital Kadamkuan Budhamurti patna 800003] |
|
|
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 Neelam kumari |
Government Ayurvedic College and Hospital |
Prasuti tantra evum stri roga Department OPD No 1 Government Ayurvedic College and Hospital Budhamurti Kadamkuan Patna Bihar 800003
Patna
BIHAR |
83406 48427
dr.neelamkumari05071995@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:N921||Excessive and frequent menstruation with irregular 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: Ashokavalkalaksheerpaka , Reference: Bhavaprakash Madhyam Khand Chikitsha Prakaran Stree Roga Adhikar 68/14, Route: Oral, Dosage Form: Ksheerpaka, Dose: 200(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients willing for trial
2 patients of age group 15 to 45 years
3 Clinical symptoms of Asrigdara
4 Patients of having any of symptoms
Excessive bleeding per vagina (amount more than 80 ml)
Prolonged bleeding per vagina (with the duration of more than 7 days)
5 Hb percentage more than equal to 8 gm per dl |
|
| ExclusionCriteria |
| Details |
1 Pregnant woman
2 Benign & Malignant growth in uterus
3 Ectopic pregnancy
4 Patients having bleeding due to abortion
5 Patients using IUCD, OCP
6 Patient with systemic disorders interfering with the present study
7 Coagulation disorders
8 Patient have been suffering from sexually transmitted diseases like AIDS, Syphilis etc
9 Bleeding sites other than the uterus
10 Uterine and pelvic pathology like Endometrial T.B , Adenomyosis, PID, Polyps etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from sign and symptoms |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determination of effect of intervention w.r.t other |
2 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="10"
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
|
In Ayurveda there are many formulations present for Asrigdara but due to easy availability of my drug I have chosen this topic "A CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASHOKAVALKALAKSHEERPAKA IN THE MANAGEMENT OF ASRIGDARA” |