| CTRI Number |
CTRI/2025/01/079697 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Aclinical trial to study effect of oral administration of indrayava yoga in patients with raktapradar |
|
Scientific Title of Study
|
Randomised open labelled control clinical study of efficacy of indrayava yoga in the management of raktapradar with special reference to 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 Mayuri Manohar Kande |
| Designation |
Pg scholar |
| Affiliation |
MUHS |
| Address |
Siddhkala ayurved mahavidyalay hospital and reaserch center pimparne road sangamner Opd no 5 ground floor streerog prasuti tantra department 422605
Opd no 5 ground floor streerog and prasuti tantra department siddhkala ayurved mahavidyalay pimparne road sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8485807070 |
| Fax |
|
| Email |
mayurikande1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rhuta N Saraf |
| Designation |
Associate professor |
| Affiliation |
MUHS |
| Address |
Siddhkala ayurved hospital and reaserch center pimparne road sangamner Opd no 5 ground floor streerog and prasuti tantra department 422605
Siddhkala ayurved mahavidyalay sangamner pimparne road sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8485807070 |
| Fax |
|
| Email |
rhutasaraf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayuri Manohar Kande |
| Designation |
Pg scholar |
| Affiliation |
MUHS |
| Address |
Siddhkala ayurved mahavidyalay hospital and reaserch center pimparne road Opd no 5 ground floor streerog and prasuti tantra department 422605
Siddhkala ayurved mahavidyalay sangamner pimparne road sangamner 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8485807070 |
| Fax |
|
| Email |
mayurikande1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| siddhkala ayurved hospital and reaserch center pimparne road sangamner 422605 district ahemadnagar Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Mayuri Manohar Kande |
| Address |
Siddhkala ayurvedic hospital and reaserch center
pimparne road Opd no5 streerog and prasuti tantra department 422606 ahemadnagar |
| 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 Mayuri manohar kande |
Siddhkala ayurved hoapital pimparne road sangamner 422605 |
siddhkala ayurvedic
hospital and reaserch center ground floor opd no. 5 streerog and prasuti tantra department pimparne road sangamner 422605
Ahmadnagar
MAHARASHTRA |
8485807070
mayurikande1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| siddhkala ayurved medical college post graduate and reaserch center sangamner 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. Ayurveda Condition: ARTAVAVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab pause 500mg | Tablet pause 500mg bd for 5 days from day 3rdto 7th day of menstrual cycle | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Indrayava granules , Reference: Bhaishajya ratnavali pradar rog chikitsa , Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Age 18-45 patients with sign and symptoms of raktapradara excessive bleeding per vaginal for consecutive 3 menstrual cycles HB More than 8gm% |
|
| ExclusionCriteria |
| Details |
Age less than 18 and more than 45 pt with blood dyacariasis,hb less than 8gm% pt with iucd ,pt with major systemic disorders like HTN ,DM,TB ,hiv, hbsag |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To reduce the rajastrava praman
Amount of blood loss by PBAC chart
Adhodar shoola
Rajastrav kalavadhi
Improve swaroop of rajastrava |
At the 4th week 8th week and final outcome after 12 weeks after interventional drug use |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access effect of interventional drugs effect on sign & symptoms & its longitivity |
To access results on 8th week & 12th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/02/2025 |
| 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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - nil
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response (Others) - nil
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
60 patient taken for study in two groups of 30_30 each one gropu will be trial in which indrayava churna with sita granules given before meal with warm water in the management of raktapradar and another group with tablet pause 500mg given for 5 days of menses effect and comparison of effect will be seen in both groups and results will be observed |