| CTRI Number |
CTRI/2024/07/071261 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the effect of Vishwaeladi Churna in Excessive menstrual bleeding. |
|
Scientific Title of Study
|
A Randomized open-labelled controlled clinical study to evaluate the efficacy of Vishwaeladi Churna 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 Anusha Purohit |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Department of Prasuti Tantra And Stree Roga, Room No, 10
Sri Sri College of Ayurvedic Science and Research Hospital, Kanakpura Road, Udayapura P.O, Bangalore- 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
8310827249 |
| Fax |
|
| Email |
anushapurohit7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti Patil |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Department of Prasuti Tantra And Stree Roga, Room No, 10
Sri Sri College of Ayurvedic Science and Research Hospital, Kanakpura Road, Udayapura P.O, Bangalore- 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9886269111 |
| Fax |
|
| Email |
shrutivinsun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anusha Purohit |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Department of Prasuti Tantra And Stree Roga, Room No, 10
Sri Sri College of Ayurvedic Science and Research Hospital, Kanakpura Road, Udayapura P.O, Bangalore- 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
8310827249 |
| Fax |
|
| Email |
anushapurohit7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Main Road, Udayapura Post, Bengaluru 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Anusha Purohit |
| Address |
Sri Sri College of Ayurvedic Science and Research, Kanakpura Road, Udayapura P.O, 560082 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Sri College of Ayurvedic Science and Research |
Kanakpura Road Udayapura PO 560082 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anusha Purohit |
Sri Sri College of Ayurvedic Science and Research Hospital |
Department of Prasuti Tantra and Stree Roga, Room No 10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakpura Road, Udayapura PO, Bangalore-560082 Bangalore KARNATAKA
Bangalore
KARNATAKA |
8310827249
anushapurohit7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee, Sri Sri College of Ayurvedic Science and Research, Kanakapura Main Road Udayapura Post Bengaluru, 560082 |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vishwaeladi Churna, Reference: Sahasrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -To be given from the second day of bleeding, till the bleeding stops, so taking it approximately as 15 days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vishwaeladi Churna, Reference: Sahasrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects with the age group of 18-45 years
2. Subjects irrespective of their marital status, religion and socio-economic status.
3. Subjects with cardinal symptoms of Asrugdara- a) Excessive blood loss during menstruation and/or b)Prolonged blood loss during menstruation.
4. Subjects with Menorrhagia- Cyclical Bleeding at normal intervals which is excessive in amount or duration.
5. Subjects willing to do self-assessment/Pictorial Blood Assessment Chart.
6. Subjects after 3 months of removal of Intra uterine contraceptive device.
7. Subjects willing to sign the consent form |
|
| ExclusionCriteria |
| Details |
Subjects between the age group of 18-45 years.
Subjects irrespective of their marital status, religion and socio-economic status.
Subjects with cardinal symptoms of Asrugdara - a) Excessive blood loss during menstruation and/or b) Prolonged blood loss during menstruation.
Subjects with Menorrhagia- Cyclical Bleeding at normal intervals which is excess in amount or duration.
Subjects willing to do self assessment / Pictorial Blood Assessment Chart.
Subjects willing to sign the consent form.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1.Significant decrease in excessive blood loss and prolonged blood loss during menstruation, associated with pain and body ache assessed based on PBAC Scoring System , subjective and objective parameters.
2.The efficacy of Vishwaeladi Churna will be established in the treatment of Asrugdara w.s.r to Menorrhagia.
|
1.Significant decrease in excessive blood loss and prolonged blood loss during menstruation, associated with pain and body ache assessed based on PBAC Scoring System , subjective and objective parameters.
2.The efficacy of Vishwaeladi Churna will be established in the treatment of Asrugdara w.s.r to Menorrhagia.
Study Duration:
Treatment Period -2 consecutive cycles
Duration of Study Period- 3 consecutive cycles
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Generation of in - depth analysed data on the different aspect of the disease.
2.Generation of data on possible unexpected drug reaction.
|
1.Significant decrease in excessive blood loss & prolonged blood loss during menstruation, associated with pain & body ache assessed based on PBAC Scoring System , subjective & objective parameters.
2.The efficacy of Vishwaeladi Churna will be established in the treatment of Asrugdara w.s.r to Menorrhagia.
Study Duration:
Treatment Period -2 consecutive cycles
Duration of Study Period- 3 consecutive cycles
|
|
|
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)
|
15/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•
Menorrhagia is defined as cyclic
bleeding at normal intervals; the bleeding is either excessive in amount
(>80ml) or duration (>7days) or both .
•
It is largely responsible for iron
deficiency anaemia which has negative effects on women health. It is considered
to be one of the most significant causes of ill health in women.
•
Menorrhagia has significant effects
on personal, social, family and work life of women thereby reducing their
quality of life. It
significantly lowers the quality of life for women by having an impact on their
personal, social, family, and work lives.
•
The condition depends largely on
hormonal therapy, prostaglandin inhibitors and anti-fibrinolytic drugs which
causes adverse affects like nausea, vomitting, GI disturbances, liver diseases
etc. They provide only symptomatic relief without providing any definite
efficacy in long term.
•
Vishwaeladi Churna is explained in Sahasrayoga, Churna
Prakarana.
•
“Vishwaelakanamusali Gokshuravamshisita Arajastadvat
Raktasravaprashamakam
Paanarthambhishajaermatam.â€
(Sahasrayoga,ChurnaPrakarana)
|