| CTRI Number |
CTRI/2024/01/061394 [Registered on: 12/01/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study on Effect of Vyoshadi Guggulu on Patients Having Uterine Fibroids |
|
Scientific Title of Study
|
A Single Arm Prospective Clinical Study on Effect of Vyoshadi Guggulu on Dhatu Pradoshaja Vikaras wsr to Uterine Fibroids |
| 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 Iram Bano Mohammed Tarique Sayed |
| Designation |
PhD Scholar |
| Affiliation |
APMs Ayurved Mahavidyalaya, Sion |
| Address |
Department of Prasuti Tantra And Stree Roga
APMs Ayurved Mahavidyalaya, Sion,Near Sion Railway Station,Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9594162992 |
| Fax |
|
| Email |
yourhighness786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Jagtap |
| Designation |
PhD Guide, HOD |
| Affiliation |
APMs Ayurved Mahavidyalaya, Sion |
| Address |
Department of Prasuti Tantra and Stree rog, APMs Ayurved Mahavidyalaya, Sion, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9594162992 |
| Fax |
|
| Email |
sujatashrikantjagtap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Iram Bano Mohammed Tarique Sayed |
| Designation |
PhD Scholar |
| Affiliation |
APMs Ayurved Mahavidyalaya, Sion |
| Address |
Department of Prasuti Tantra and Stree rog, APMs Ayurved Mahavidyalaya, Sion, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9594162992 |
| Fax |
|
| Email |
yourhighness786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prasuti Tantra and Stree rog, APMs Ayurved Mahavidyalaya, Sion, Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Iram Sayed |
| Address |
APMs Ayurved Mahavidyalaya,Sion. Near Sion Railway Station, 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 Iram Bano Sayed |
APMs Ayurved Mahavidyalaya,Sion |
Department of Prasuti Tantra and Stree rog, APMs Ayurved Mahavidyalaya, Sion, Mumbai
Mumbai
MAHARASHTRA |
9594162992
yourhighness786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AyurvedMahvidyalayavaSethVaMaDjarmarthaDawakhanaSion |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N719||Inflammatory disease of uterus, unspecified. Ayurveda Condition: ayurveda, (2) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyoshadi Guggulu, Reference: Vrunda Madhav , Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Pt having single or multiple Uterine Fibroids of less than 5cms |
|
| ExclusionCriteria |
| Details |
1.Patient having fibroid of size more than 5 cm as per USG report.
2.Ovarian tumour, tubo-ovarian mass and malignant tumours along with fibroid.
3.Prediagnosed Cases of Cancer.
4.Patient below the age of 20 years and above the age of 50years.
5.Women with Hb < 7 gm%.
6.Pregnant women with fibroid.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vyoshadi guggulu is Effective in management of Uterine Fibroids given orally everyday for 3 consecutive mnths assessed every month symptomatically n final outcome after 3 months |
Monthly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vyoshadi Guggulu Does not have any role in management of Uterine Fibroids |
Monthly |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/01/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Uterine Fibroids is major findings in the sonographic findings of many women as a gynacological flaw disturbing their menstrual cycle in many which is becoming a major obstacle in women health nowadays. Surgery for very small fibroids or in young unmarried or nulliparous women is a topic of worry for many women. So This trial is proposed to see the effect of Vyoshadi Guggulu given orally for a period of 3 consecutive months for the management of Uterine Fibroids. |