| CTRI Number |
CTRI/2024/08/072336 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of dysfunctional uterine bleeding through ayurvedic line of management |
|
Scientific Title of Study
|
Controlled clinical study to evaluate the effect of pradarahara kashaya and patrangasava in the management of asrigdara w.s.r to Dysfunctional uterine bleeding |
| 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 Pooja Gundagi |
| Designation |
2nd year MS (AYU) Scholar |
| Affiliation |
2nd year M.S. Ayu Scholar |
| Address |
Department of prasuti tantra and streeroga
Shree jagadguru gavisiddeshwara ayurvedic medical college post graduation studies and research Center Koppal, Karnataka
Shree jagadguru gavisiddeshwara ayurvedic medical college post graduation studies and research Center Koppal Karnataka
Koppal
KARNATAKA
583231
India |
| Phone |
9972232291 |
| Fax |
|
| Email |
gundagipooja20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niveditha Somalapur |
| Designation |
Associate Professor |
| Affiliation |
Associate professor |
| Address |
Shree jagadguru gavisiddeshwara ayurvedic medical college post graduation studies and research Center Koppal, Karnataka
Shree jagadguru gavisiddeshwara ayurvedic medical college post graduation studies and research Center Koppal, Karnataka
Koppal
KARNATAKA
583231
India |
| Phone |
9886800413 |
| Fax |
|
| Email |
nivedita.somalapur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niveditha Somalapur |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor |
| Address |
Shree jagadguru gavisiddeshwara ayurvedic medical college post graduation studies and research Center Koppal, Karnataka.
Shree jagadguru gavisiddeshwara ayurvedic medical college post graduation studies and research Center Koppal, Karnataka
KARNATAKA
583231
India |
| Phone |
9886800413 |
| Fax |
|
| Email |
nivedita.somalapur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center |
|
|
Primary Sponsor
|
| Name |
Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center |
| Address |
Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center koppal Karnataka 583231 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pooja Gundagi |
Shree jagadguru gavisiddeshwara ayurvedic medical college post graduation studies |
Department of prasuti tantra and streeroga
Koppal
Karnataka
Koppal
KARNATAKA |
9972232291
gundagipooja20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree jagadguru gavisiddeshwara ayurvedic medical college post graduation studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:3||Administration. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, (2) 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: Pradarahara kashaya, Reference: Sahastrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Patrangasava, Reference: Sahasrayoga, Route: Oral, Dosage Form: Asava, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients fulfilling the diagnosis criteria
Patients with age group of 18-40years
Both married and unmarried women
Patients with hb%>8gm/dl
Cardinal symptoms of asrigdhara with min. Two months history |
|
| ExclusionCriteria |
| Details |
Bleeding from sites other than uterus
Bleeding due to abortions
Bleeding per Vagina after menopause
Patients with systemic and endocrine disorders
Patients with IUCD and taking OPC
PID, bening and malignant growth in the uterus |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To control excessive bleeding |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
00 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/08/2024 |
| 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="0"
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
|
Acharaya susruta considers blood as life1 Acharya Sushruta mentions Atiprasangena and Anrtavapi i.e., excessive or Prolonged bleeding and intermenstrual bleeding as Pradara, which is associated with Angamarda and Vedana.2 Asrigdara can be correlated to Dysfunctional uterine bleeding(DUB) which is defined as a state of abnormal uterine bleeding without any clinically detectable organic, systemic and iatrogenic causes. Currently DUB is defined as a state of abnormal uterine bleeding following anovulation due to dysfunction of hypothalamo-pituitary-ovarian axis (Endocrine origin)3 The Prevalence varies widely but an Incidence of 10% amongst new patients attending the outpatient seems logical.3 In India, about 13-23 % of women experience episodes of DUB4 About 1-2% of women with improperly managed anovulatory bleeding eventually may develop endometrial cancer5 The term DUB is used to describe abnormal bleeding for which no specific cause was found6. Conventional western medicine offers the use of COCs, Progestins, Androgens & Agonist of Gonadotropin- releasing Hormone (GnRH), NSAIDs7. Side effects of COCs include increased risk of venous and arterial Thromboembolism (DVT, PE, MI, stroke), mild increase in blood pressure, and possible increases in breast and cervical cancer risk8. The treatment principles of Raktayoni are adopted in Asrigdara, the haemostatic drugs should be used in the management of Asrigdara.9 Keeping this in mind pradarahara Kashaya is selected for the study10. The Pradarahara Kashaya yoga is having kapha pittahara,Vata pittahara, Tridoshahara properties, and acts as Stambana, Vrishya, Rasayana,Balya and Grahi.11 Thus, an attempt is made to know the effect of Pradarahara Kashaya in the management of Asrigdara w.s.r. to Dysfunctional Uterine Bleeding. |