| CTRI Number |
CTRI/2020/01/022839 [Registered on: 17/01/2020] Trial Registered Prospectively |
| Last Modified On: |
17/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the add on effectiveness of Palandu peya as a food in the management of Raktapradara(Menorrhagia) |
|
Scientific Title of Study
|
A clinical study to evaluate the add on effectiveness of Palandu peya in Raktapradara(Menorrhagia). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reshma Shaji |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,BM road,Thanniruhalla,Hassan
15th Kavikeshiraja road,near SVVM school,Gavipuram extension,2nd floor,Banashankari stage 1,Srinagar, Bangalore. 560050
Bangalore
KARNATAKA
573201
India |
| Phone |
9400711866 |
| Fax |
|
| Email |
reshmashaji6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M B Kavita |
| Designation |
Associate Professor |
| Affiliation |
Sri Manjunatheswara College of Ayurveda and Hospital |
| Address |
Department of Swasthavritta and Yoga, Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,BM road,Thanniruhalla,Hassan
BM road,Thanniruhalla,Hassan,573201
Hassan
KARNATAKA
573201
India |
| Phone |
9986432954 |
| Fax |
|
| Email |
drmbkavita@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reshma Shaji |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,BM road,Thanniruhalla,Hassan
15 th Kavikeshiraja road, near SVVM school,Gavipuram extension,2nd floor, stage 1,Banashankari,Srinagar,Bangalore,Karnataka
Bangalore
KARNATAKA
573201
India |
| Phone |
9400711866 |
| Fax |
|
| Email |
reshmashaji6@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Reshma Shaji |
| Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,BM road,Thanniruhalla,Hassan |
| 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 M B Kavita |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital |
Department of Swasthavritta OPD number 9, Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital,BM road,Thanniruhalla,Hassan
Hassan
KARNATAKA |
9986432954
drmbkavita@sdmcahhassan.org |
|
|
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: N920||Excessive and frequent menstruation with regular cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A Clinical study to evaluate the add on effectiveness of Palandu peya in raktapradara(menorrhagia) |
Shamana cikitsa with Bolabaddha rasa 2BD after food and Pushyanuga churna 5gm BD with luke warm water.Palandu peya 200 ml is given along with shamana cikitsa for one month to study group while control group is on samana cikitsa only. |
| Comparator Agent |
A clinical study to evaluate the add on effectiveness of Palandu peya in raktapradara(menorrhagia) |
Shamana cikitsa with Bolabaddha rasa 2BD after food and Pushyanuga churna 5gm BD with lukewarm water for one month. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Subjects presenting with prolonged or excessive bleeding through vagina in normal cycles in at least past two cycles.
Subjects in reproductive age group.
Subjects ready to sign informed consent form. |
|
| ExclusionCriteria |
| Details |
Subjects with history of coagulation or fibrinolytic disease.
Known case of sexually transmitted diseases.
Subjects usually intrauterine devices and hormonal pills.
History of malignancies.
Diagnosed case of Inflammatory bowel disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A Clinical study to evaluate the add on effectiveness of Palandu peya as a pathya in the management of raktapradara(menorrhagia) |
Assessment will be done on baseline treatment,assessed on 15 th day and after completion of study on 31st day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to reduce excessive bleeding and thereby preventing complications like anemia. |
15 th day and after completion of study. |
|
|
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 |
|
Date of First Enrollment (India)
|
17/01/2020 |
| 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="6"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pathya (therapeutic diet) plays a key role in
the management of diseases. Raktapradara (Menorrhagia) is mainly one
of those diseases found in women of reproductive age group where excessive
bleeding during menstrual cycle(>80 ml) is the main symptom. It is clearly
stated in classics that the disease is specifically due to consumption of
unsuited or unwholesome food. Palandu
peya mentioned as pathya in raktapradara is expected to decrease the excessive
bleeding through vagina and thereby reducing the complications like anemia. The
ingredients of this are easily available, and can easily be prepared at home. The ingredients include palandu, surasa leaves, tila taila, go ghrta, shali and jala. Keeping in view these facts, this study is conducted to evaluate the add on
effectiveness of palandu peya in
raktapradara. |