| CTRI Number |
CTRI/2025/02/079899 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of garjar beej churn vati in oligohypomenorrhea |
|
Scientific Title of Study
|
Randomised controlled clinical study to evaluate the efficacy of Garjar beej churn Vati in artavkshaya with special reference to oligohypomenorrhea |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rani Keshav kadam |
| Designation |
Pg scholar |
| Affiliation |
Shree saptshrungi ayurved mahavidyalaya and hospital nashik |
| Address |
Department of prasutitantra and stree rog Shree Saptashrungi sourced mahavidyala hirawadi kamal nagar Panchavati Nashik 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
702733620 |
| Fax |
|
| Email |
kadamrani142@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rani Keshav kadam |
| Designation |
Pg schlor |
| Affiliation |
Shree saptshrungi ayurved mahavidyalal and hospital Nashik |
| Address |
Department of prasutitantra and stree rog shree Saptashrungi ayurved mahavidyalayal and hospital Nashik 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
7020733620 |
| Fax |
|
| Email |
kadamrani142@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Sadashiv more |
| Designation |
Professor and HOD |
| Affiliation |
Shree saptshrungi ayurved mahavidyala |
| Address |
OPD no 3 Department of prasuti tantra and stree rog Shree saptshrungi ayurved mahavidyalaya and hospital nashik
OPD no 3 Department of prasuti tantra and stree rog Shree saptshrungi ayurved mahavidyalaya and hospital nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9423934506 |
| Fax |
|
| Email |
moresunil263@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved mahavidyala and hospital Kamal nagar Hirawadi Nashik 422003 |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi ayurved mahavidyalay Kamal nagar nashik 420003 |
| Address |
OPD number 23Department of prasutitantra tantra and stree rog Shree saptshrungi ayurved mahavidyalaya and hospital kamal nagar nashik 422003 |
| 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 Rani Keshav kadam |
Shree Saptashrungi Ayurved mahavidyala and hospital Kamal nagar nashik |
OPD number 3 department of prasutitantra and stree rog Shree Saptashrungi Ayurved mahavidyalaya and hospital Hirawadi kamal nagar Nashik 422003
Nashik
MAHARASHTRA |
7020733620
kadamrani142@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Shree saptshrungi ayurved mahavidyalaya and hospital nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N926||Irregular menstruation, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Garjarbeej, Reference: Ayurved Saar sangraha , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Age group 18 to 35 years
Menstrual duration more than 35 days and menstrual bleeding flow less than 2 days
The interval between two cycles exceeds than 35 days
All female patient who have signed written informed consent
|
|
| ExclusionCriteria |
| Details |
Patient age below 18 years and above 35 years
ANC and PNC patient
Patient having disease related to urogenital system
Patient having uterine pathology like fibroid uterine cyst endometriosis PID
Known case of CA cervix and endometrial CA
Anemia hb less than 8 gm |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms and regulation of menstruation |
2-3month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| One month |
2 to 3 month |
| Regulation of menstruation |
2-3month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1 |
|
Date of First Enrollment (India)
|
15/02/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
The menstrual cycle which involves the shading of endometrial which was prepared in anticipation of providing a bed for fertilized ovum Artavkshaya involves menstrual bleeding that occurs more than 35 days and lasting for 2-3 days Primary objective To study the efficacy of garjar beej churn vati in artavkshaya Secondary objective To study ayurvedic literature on artavkshsya as per ayurveda To study modern literature on artavkshsya To study the preparation of garjar beej churn vati Participants 60
Primary outcomes Reduce sign and symptoms Secondary outcomes Regulation of cycles
Patient will be observed before and after treatment. All observations and data Coll after the final assessment will be subjected to statistical analysis as mentioned
|