CTRI Number |
CTRI/2020/11/028989 [Registered on: 09/11/2020] Trial Registered Prospectively |
Last Modified On: |
06/11/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Other (Specify) [Curative ] |
Study Design |
Other |
Public Title of Study
|
Kashmari phal in excessive bleeding during menstruation |
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF KASHMARI PHAL IN ASRIGDARA |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Vaishali Dave |
Designation |
Assistant Professor |
Affiliation |
J S Ayurveda Mahavidyalay |
Address |
Department of Prasutitantra ans striroga , JS Ayurveda Mahavidyalay,
College Road, Nadiad Sai Smruti 188/1
Sector 2B
Opp. Infocity
382007
Gandhinagar GUJARAT 387001 India |
Phone |
9662140078 |
Fax |
|
Email |
vaishalivasavda@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vaishali Dave |
Designation |
Associate Professor |
Affiliation |
J S Ayurveda Mahavidyalay |
Address |
Room no 205, Department of Prasutitantra evam Strirog JS Ayurveda Mahavidyalay,
College Road, Nadiad Sai Smruti 188/1
Sector 2B
Opp. Infocity
382007
Gandhinagar GUJARAT 387001 India |
Phone |
9662140078 |
Fax |
|
Email |
vaishalivasavda@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vaishali Dave |
Designation |
Assistant Professor |
Affiliation |
J S Ayurveda Mahavidyalay |
Address |
Room no 205, Department of Prasutitantra evam Striroga ,
JS Ayurveda Mahavidyalay,
College Road, Nadiad Sai Smruti 188/1
Sector 2B
Opp. Infocity
382007
Gandhinagar GUJARAT 387001 India |
Phone |
9662140078 |
Fax |
|
Email |
vaishalivasavda@gmail.com |
|
Source of Monetary or Material Support
|
JS Ayurveda Mahavidyalaya, Nadiad |
|
Primary Sponsor
|
Name |
DrVaishali Dave |
Address |
A/8 Lalbaug Society
Opp. Umabhavan, Amroli
Surat
Gujarat
India 394107 |
Type of Sponsor |
Other [Self] |
|
Details of Secondary Sponsor
|
Name |
Address |
NIL |
NIL |
NIL |
NIL |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DrVaishali Dave |
JS Ayurved Mahavidyalay |
Room no 205, Department of Prasutitantra evam striroga
J S Ayurveda Mahavidyalaya
College Road
Nadiad Kheda GUJARAT |
9662140078
vaishalivasavda@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ICEHR |
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
|
Type |
Name |
Details |
Intervention |
Kashmari phal |
Kashmari phal 5gm Orally with warm water twice a day for 2 months. |
Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
13.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Female |
Details |
Age 13- 45 years. and willing to give their consent to participate in the study.
Patients with pratyatma lakshanas of asrigdara.
Patients diagnosed as DUB |
|
ExclusionCriteria |
Details |
Patients with chronic illness.
Patients using intrauterine contraceptive device.
Patients with uterine and Pelvic pathology.
Benign and malignant growth.
Threatened , spontaneous or incomplete/ Ectopic pregnancy |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Kashmari phal will be effective in controlling excessive bleeding during menstruation |
4 week , then 8th week after treatment |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reoccurrence of Condition will be prevented |
after 2 months |
|
Target Sample Size
|
Total Sample Size="5" Sample Size from India="5"
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
|
N/A |
Date of First Enrollment (India)
|
14/11/2020 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nill |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Rhythm and periodicity are the characteristics of a woman’s life, so is her menstruation.
Every healthy woman menstruates regularly and rhythmically every month during her reproductive
age. Any change in this normal rhythm brings curious concern to women. Dysfunctional uterine
bleeding(DUB) is excessive abnormal uterine bleeding for which organic causes or pelvic pathology
cannot be found.1 As we see symptoms of Asrigdara it appears analogues to DUB.
The WHO reports that 18 million women in the reproductive period suffers from DUB. Excessive
menstrual bleeding is a significant cause of morbidity during the reproductive years.2Dysfunctional
Uterine Bleeding has a wide spectrum of presentations that range from heavy uterine
bleeding that warrant hospital admission and emergency treatment to occasional irregular
uterine spotting anytime throughout the cycle. The treatment options in these conditions by
modern medicines often require a combination of invasive surgical procedures. Taking into account
the side effects and adverse effects, The Ayurvedic management can be recommended as a safer,
feasible and effective therapy for the management of heavy menstrual bleeding. The first line of
treatment for Asrukdar is Raktapittanashana Chikitsa.3Acharya charaka mentioned kashmariphala
as best Raktapitta hara and Rakta sangrahaka4. Compare to other medication kashmari phal is
easily available and cost effective. Hence Kashmari is selected as a trial drug to cure Asrukdar.
|