| CTRI Number |
CTRI/2025/03/082543 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| 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
|
To study the oral effect of jyotishmati vati in patient of aratavshaya |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABELLED CONTROLLED CLINICAL TRIAL TO ASSESS AN EFFECT OF DURVA SWARASA BHAVIT JYOTISHMATI VATI IN ARTAVKSHAYA WITH SPECIAL REFERENCE TO OLIGOMENORRHEA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Manisha Rajkumar vishwakarma |
| Designation |
PG scholar |
| Affiliation |
Siddhakala ayurved mahavidyalaya and research centre sangamner |
| Address |
siddhakala ayurved mahavidyalaya sangamner Siddhakala ayurved hospital pimparane road sangamner Khurd sangamner 422605 Ahmadnagar
siddhakala ayurved mahavidyalaya sangamner Siddhakala ayurved hospital pimparane road sangamner Khurd sangamner 422605 Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8108297882 |
| Fax |
|
| Email |
manishavishwakarma20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipul vishwanath bhujbal |
| Designation |
Head of department of streeroga prasutitantra |
| Affiliation |
Siddhakala ayurved mahavidyalaya and research centre sangamner |
| Address |
Ground floor OPD number 5 streeroga prasutitantra department siddhakala ayurved mahavidyalaya pimparane road sangamner 422605 ahmadnagar
Ground floor OPD number 5 streeroga prasutitantra department siddhakala ayurved mahavidyalaya pimparane road sangamner 422605 ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9960840214 |
| Fax |
|
| Email |
vipulbhujbal1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Manisha Rajkumar Vishwakarma |
| Designation |
Pg scholar |
| Affiliation |
Siddhakala ayurved Mahavidyalaya and research centre sangamner |
| Address |
Ground floor OPD number 5 streeroga prasutitantra department siddhakala ayurved mahavidyalaya pimparane road sangamner 422605 ahmadnagar
Ground floor OPD number 5 streeroga prasutitantra department siddhakala ayurved mahavidyalaya pimparane road sangamner 422605 ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8108297882 |
| Fax |
|
| Email |
manishavishwakarma20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala ayurved mahavidyalaya and research centre pimparane road Khurd sangamner ahmednagar 422605 |
|
|
Primary Sponsor
|
| Name |
Vd Manisha rajkumar vishwakarma |
| Address |
Siddhakala ayurved mahavidyalaya and research centre pimparane road khurd sangamner 422605 |
| 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 Manisha Vishwakarma |
Siddhakala ayurved mahavidyalaya sangmner |
Ground floor OPD no-5 Striroga evum prasutitranta department Siddhakala ayurvedic mahavidyalaya and research centre pimparane road Ahmadnagar 422605
Ahmadnagar
MAHARASHTRA |
8108297882
manishavishwakarma20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of ayurved research and statistics committee of siddhakala ayurved mahavidyalay sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rajapravartini vati, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jyotishmati vati, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Age 15 to 35 yrs.
Selection irrespective of marital status, parity, socio-economic
status.
Patients having signs & symptoms of Artavkshaya.
Those having scanty menstrual bleeding.
Those females having quantity of bleeding less than 80 ml .
Hb less than 8gm |
|
| ExclusionCriteria |
| Details |
Known patients of blood dyscrasias.
Known patients of major systemic diseases that are likely to
influence menstrual rhythm. For e.g.; HTN, DM, TB, HIV, Thyroid,
Nephrotic disorders.
Known patients of malignancy, cervical erosion, polyp,
endometriosis, tubo-ovarian mass.
Known case of structural anomalies of genital organs.
Patients using IUCD’s.
Patients undergoing treatment for any other serious illness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of durva swaras bhavit jyotishmati vati in artavkshaya with special reference to oligomenorrhea |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study detail about artavkshaya
To study properties of durva swaras bhavit jyotishmati vati |
3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
25/03/2025 |
| 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 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
|
Study is randomized open labelled clinical trial to asses an effect of durva swaras bhavit jyotishmati vati in artavkshaya with special reference to oligomenorrhea Total sample size is 90 There are 2 groups and each group have 45 samples Group A is trail group and group B is control group A group have durva sawaras bhavit Jyotishmati vati with koshna jala for 30 days for 3 consecutive cycles B group have rajpravartini vati with koshna jala for 30. Days for 3 consecutive cycles Than follow on 1st 3rd and 7th day of menstrual cycle Analysis of data and interpretation of results. |