| CTRI Number |
CTRI/2024/01/061309 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study difference between effect of atibala sharkara choorn and yashtimadhu sharkara choorna in excessive bleeding during menstruation(raktapradar) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical study to evaluate the efficacy of atibala sharkara choorn and yashtimadhu sharkara choorna in the management of raktapradar of age group 20 to 40 years |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja jaysing gaikwad |
| Designation |
PG scholar |
| Affiliation |
PDEAS college of ayurved and research centre |
| Address |
PDEAS college of ayurved and research centre third floor stree rog and prasuti tantra department sector25 nigadi pune
Pune
MAHARASHTRA
411044
India |
| Phone |
756004882 |
| Fax |
|
| Email |
poojagaikwad2040@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali vijay jadhav |
| Designation |
Professor |
| Affiliation |
PDEAS college of ayurved and research centre,nigadi,pune |
| Address |
PDEAS college of ayurved and research centre third floor stree rog and prasuti tantra department sector25 nigadi pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9284165929 |
| Fax |
|
| Email |
anjali.anjali.jadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja jaysing gaikwad |
| Designation |
PG scholar |
| Affiliation |
PDEAS college of ayurved and research centre |
| Address |
PDEAS college of ayurved and research centre third floor stree rog and prasuti tantra department sector25 nigadi pune
MAHARASHTRA
411044
India |
| Phone |
756004882 |
| Fax |
|
| Email |
poojagaikwad2040@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS college of ayurved and research centre sector 25 nigadi pune411044 |
|
|
Primary Sponsor
|
| Name |
PDEAS college of ayurved and research centre |
| Address |
Nigadi sector 25 pune 411044 |
| Type of Sponsor |
Private medical college |
|
|
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 Jaysing Gaikwad |
Ayurved rugnalya and sterlling multispeciality hospital, nigadi, pune |
Ayurved rugnalya and sterlling multispeciality hospital,streerog and prasuti tantra department opd no 119 nigadi, sector 27,pune 411044 maharashtra
Pune
MAHARASHTRA |
7756004882
poojagaikwad2040@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAS college of ayurved and research centre Institutional ethics 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. Ayurveda Condition: RAKTATIPRAVRUTTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Atibala sharkara , Reference: Yogratnakar uttarkhand pradarchikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu sharkara choorn , Reference: Bhavprakash , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Tandulodak), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient having clinical symptoms of raktapradar means amount of excessive bleeding and associated symptoms such as angamarda vedana adhodarshool katishool atleast 02 among these during menstrual cycle
|
|
| ExclusionCriteria |
| Details |
History of congenital anamoly in genital organs such as bicornuate uterus septate uterusvaginal agenesis
Bleeding due to iucd ocp
Known case of polyp adenomyosis fibroid diabetes mellitus
Tubercular cervicitis endometriosis
Haemorrhagic disorder
Hb less than 8 gm per dl |
|
|
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 |
| To study the efficacy of atibala sharkara choorna in management of raktapradar for 3 consecutive cycles on the basis of menstrual flow |
3 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
15/02/2024 |
| 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 Applicable |
| 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
|
Raktapradar means per vaginal excessive bleeding .it hamper daily activities of women .there is dushti of vat pitta and rakta dosha. there are many allopathy drugs just give temporary relief. But ayurvedic drug such as atibala sharka and yashtimadhu sharka provide releif from excessive per vaginal bleeding and as they are madhur and sheet gunatmak they provide santarpan which is lost due excessive blood loss.as rakta is called jeevan.rakta and pitta dushti can clear by this drug .n rakta prasadan occurs .so use of this drug can avoid side effect of many modern drugs or prevent furtur surgeries |