| CTRI Number |
CTRI/2024/04/066040 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To treat PCOS(Polycystic Ovarian Syndrome)with Ayurvedic Medicine as it is the most burning issue in the females of the reproductive age group. |
|
Scientific Title of Study
|
COMPARATIVE AND CLINICAL STUDY OF TRIKATU CHURNA AND PIPPALI CHURNA IN ARTHAVAKSHAYA W.S.R. TO PCOS |
| 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 Koti Rohitha |
| Designation |
Post Graduate Scholar |
| Affiliation |
Dr B R K R Government Ayurvedic Medical College |
| Address |
Post Graduate Department Of Dravya Guna
Dr B R K R Government Ayurvedic Medical College
Erragadda
Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9121882909 |
| Fax |
|
| Email |
rohitha929@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR G SWARUPA RANI |
| Designation |
PROFESSOR |
| Affiliation |
Dr B R K R Government Ayurvedic Medical College |
| Address |
Post Graduate Department Of Dravya Guna
Dr B R K R Government Ayurvedic Medical College
Erragadda
Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9441905338 |
| Fax |
|
| Email |
gattusr135@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR G SWARUPA RANI |
| Designation |
PROFESSOR |
| Affiliation |
Dr B R K R Government Ayurvedic Medical College |
| Address |
Post Graduate Department Of Dravya Guna
Dr B R K R Government Ayurvedic Medical College
Erragadda
Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9441905338 |
| Fax |
|
| Email |
gattusr135@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R K R Government Ayurvedic Medical College
Erragadda
Hyderabad
Telangana
India
500038 |
|
|
Primary Sponsor
|
| Name |
Dr B R K R Government Ayurvedic Medical College |
| Address |
Dr B R K R Government Ayurvedic Medical College
Erragadda
Hyderabad
500038 |
| Type of Sponsor |
Government 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 Koti Rohitha |
DR B R K R Government Ayurvedic Hospital |
Prasuthi and Stree Roga Vibhaga
OPD No 15
Hyderabad
TELANGANA |
9121882909
rohitha929@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICAL COMMITTEE OF DR BRKR GOVT AYURVEDIC COLLEGE HYDERABAD |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trikatu , Reference: Susrutha Samhitha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Ghrita), Additional Information: -(2) Medicine Name: Pippali, Reference: Susrutha Samhitha , Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Ghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Having irregular menstrual cycles with cycle interval of more than 35 days.
2.Menstrual abnormalities like-Oligomenorrhoea,hypomenorrhea.
3.Diagnosed case of PCOS by USG.
4.Pre-Obesity(Over Weight)
5.Obesity. |
|
| ExclusionCriteria |
| Details |
1.Female patients of age below 20 and above 45 years of age.
2.Heavy bleeding (Menometrorrhagia,Menorrhagia)
3.Garbhashaya Arbuda(Malignancy of genital tract).
4.Janma Jatha sthree janananga vikruti(Congenital abnormalities of genital organs).
5.Suffering from systemic illness like like Chronic Diabetes Mellitus,HTN,Hypothyroidism.
6.Pregnant women and lactating women.
7.Peptic ulcers,Gastric ulcers,Duodenl ulcers,Esophageal ulcers. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of bleeding must be improved and irregularity in their menstrual cycle must be corrected.Amount of bleeding and quantity of bleeding must be improved. |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hirsutism must be reduced.Variation must be noted in their BMI compared to Before and After Treatment. |
90 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/04/2024 |
| 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="0"
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
|
The Polycystic Ovarian Syndrome is the most common endocrine disorder affecting women mainly of 15-35years of age group.30-50% of women with PCOS have 3 times higher risk of miscarriage than a normal woman.PCOD is a wide spread reproductive disorder that encompasses many associated health conditions and has an impact on various metabolic processes.It increases the risk of insulin resistance(IR),Type 2 Diabetes,Obesity and Cardiovascular diseases.As both the drugs Trikatu and Pippali are non toxic, easily available,Cost effective, and also as Trikatu Churna has the following healing properties like it’s phytochemical PIPERENE is a great bio enhancer ,Hypo-Glycaemic,Hypo-lipidemic,Anti-inflammatory and as PIPERENE present in pippali has Hypocholesterolaemic activity and also as 5-ALPHA REDUCTACE INHIBITORS are a class of medications with antiandrogeniceffects,and as these are present in maricha ,which is known to be effective in the treatment of hirsutism in women,so,as a whole taking into consideration all these above said factors, ans also despite the growing incidence of this syndrome, it is selected to treat on ayurvedic basis & provide an effective care. |