| CTRI Number |
CTRI/2023/08/056670 [Registered on: 21/08/2023] Trial Registered Prospectively |
| Last Modified On: |
18/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of regimen of latakarnj beej churna and tamra bhasma as tab lamra and latakaranj beej churna as tab lata in aartavkshay in polycystic ovarian syndrome |
|
Scientific Title of Study
|
Randomized controlled clinical trials of tab lamra regimen latakaranj beej churna and tamra bhasma and tab lata regimen latakaranj beej churna in aartavkshay with special reference to polycystic ovarian syndrome |
| 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 Simran Abdulraheman Shaikh |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 06 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved
Hospital Ashta Tal WalWa Dist Sangli
Tal WalWa Dist Sangli
MAHARASHTRA
416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
7038911586 |
| Fax |
|
| Email |
simranbams041@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radha Phadnis |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra
Hon Shri Annasaheb Dange
Ayurved Medical College Post Graduate And Research Center Ashta
Tal WalWa Dist Sangli
MAHARASHTRA
416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9545114545 |
| Fax |
|
| Email |
radhakulkarni6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radha Phadnis |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra
Hon Shri Annasaheb Dange
Ayurved Medical College Post Graduate And Research Center Ashta
Tal WalWa Dist Sangli
MAHARASHTRA
416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9545114545 |
| Fax |
|
| Email |
radhakulkarni6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research
Center Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Simran Abdulraheman Shaikh |
| Address |
OPD no 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved
Hospital Ashta Tal Walwa Dist Sangli |
| 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 Simran Abdulraheman Shaikh |
Hon Shri Annasaheb Dange Ayurved Medical College And Dhanvantari Ayurved Hospital Ashta |
OPD no 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved
Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
7038911586
simranbams041@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Ovral L | Tab Ovral L From 5 th Day to 25 th Day Of Each Menstrual Cycle For Next 180 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Group 1 Tab Lamra Group 2 Tab Lata, Reference: Group 1 Rasatarangini Group 2 Bhavprakash and Shodhal Nighantu , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 650(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: jala), Additional Information: -Tab Lamra
From 5 th Day Of Menstrual Cycle Of Treatment to. Next 45 Days Followed By Tab Lata For Next 135 DaysTab Lata 500 Mg From 5 th Day Of Menstrual Cycle Of Treatment Upto 180 Days
Tab Lata 500 Mg From 5 th Day Of Menstrual Cycle Of Treatment Upto 180 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women Of Age Group 18-40 yrs Irrespective Of Marital Status
Known Cases Of PCOS
USG Showing Polycystic Appearance
Patient Fulfilling Rotterdam Criteria Require Any Two Of Following Three Criteria For Diagnosis Of PCOS
Oligomenorrhea And Amenorrhea
Hyperandrogenism Clinical And Biochemical
USG Suggestive Of
Ovarian Volume Greater Than Or Equal To 10 Cm Cube
Polycystic Ovaries
Ovarian Diameter 2-9 mm |
|
| ExclusionCriteria |
| Details |
Known Cases Of Fibroid Adenomyosis Endometriosis Anaemia Hb less than 7
Diabetes Mellitus
Pregnant And Lactating Women
Pittapradhan Prakruti |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate The Efficacy Of Regimen Of Tab Lamra Plus Tab Lata In Aartavkshay With Special Reference To Pcos |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Assess Properties Positive Effects And Untoward Effect Of Latakarnj Beej Churna And Tamra Bhasma Regarding Aartavkshay In PCOS
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
31/08/2023 |
| 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 - NO
|
|
Brief Summary
|
As PCOS Has 36% Prevalence It’s Becoming Burning Issue Regarding Women Reproductive Health Current Study Is Randomized Controlled Clinical Trial To Check Effectiveness Of Regimen Of Latakaranj Beej Churna Plus Tamra Bhasma As Tab Lamra And Latakarnj Beej Churna As Tab Lata In Aartavkshay In PCOS Study Consists Of Two Trial Groups A B And One Control Group C Drugs A Group Tab Lamra 650 Mg First 45 Days From 5 th Day Of Menstrual Cycle Of Treatment Followed By Tab Lata 500 Mg For Next 135 Days Orally with water Before Meal Group B Tab Lata From 5 th Day Of Menstrual Cycle To Next 180 Days Orally With Water Before Meal Group C Tab Ovral L 5 th Day To 25 th Day Of Each Menstrual Cycle Of Treatment For Next 180 Days Orally With Water HS |