| CTRI Number |
CTRI/2025/01/079249 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Varaasanadi kwatha and Vidanganagaradi churna in lowering weight and BMI in women with PCOS |
|
Scientific Title of Study
|
Effect of Varaasanadi kwatha and Vidanganagaradi churna in reducing Body Mass Index (BMI) of Poly Cystic Ovarian Syndrome patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreelakshmi CC |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department Of Prasuti Tantra and Streeroga,Government Ayurveda College Tripunithura Ernakulam,Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9946816950 |
| Fax |
|
| Email |
sreelakshmicc1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajitha R Warriar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department Of Prasuti Tantra and Streeroga,Government Ayurveda College Tripunithura Ernakulam,Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9947144562 |
| Fax |
|
| Email |
drrajithawarriar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajitha R Warriar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department Of Prasuti Tantra and Streeroga,Government Ayurveda College Tripunithura Ernakulam,Kerala
KERALA
682301
India |
| Phone |
9947144562 |
| Fax |
|
| Email |
drrajithawarriar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Tripunithura ,Ernakulam,Kerala,India 682301 |
|
|
Primary Sponsor
|
| Name |
Sreelakshmi CC |
| Address |
PG Scholar,Department of Prasuti Tantra and Streeroga, Government Ayurveda College Tripunithura,Ernakulam,Kerala,682301 |
| 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 |
| Sreelakshmi CC |
Government Ayurveda college Tripunithura |
Department Of Prasuti Tantra and Streeroga Ground floor Hospital building 682301 Ernakulam Kerala
Ernakulam
KERALA |
9946816950
sreelakshmicc1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee for Ethics in Research (Institutional Review Board),Govt.Ayurveda College Tripunithura, Kochi, Kerala-682301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N838||Other noninflammatory disorders ofovary, fallopian tube and broad ligament. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varaasanadi kwatha , Reference: Sahasrayogam sthoulyaprakaranam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Vidanganagaradi churnam, Reference: Ashtangahridaya Sutrasthana 14/24, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Female patients within age group 18-45 years attending outpatient department of government ayurveda college Tripunithura who are willing to give written consent
Poly Cystic Ovarian Syndrome patients diagnosed according to ESHRE ASRM criteria 2018
BMI greater than or equal to 25 kg per m2 |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactating mothers ,patient with heavy menstrual bleeding and prolonged spotting ,known case of uncontrolled diabetes and uncontrolled hypertension ,known case of systemic illness like cardiovascular diseases ,kidney ,liver diseases,hemoglobin less than 7 gm percentage,use of statins or other medicines known or suspected to affect reproductive or metabolic functions,known case of malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of varaasanadi kwatha and vidanganagaradi choorna in reducing Body Mass Index of PCOS patients
|
after 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| waist circumference characteritics of menstrual cycle nature size or volume of ovary |
after 90 days |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
02/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/02/2025 |
| 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
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - pdf files
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Polycystic Ovarian Syndrome (PCOS) is a prevalent endocrine disorder affecting women of reproductive age, characterized by ovulatory dysfunction, hyperandrogenism, and polycystic ovaries. It presents with short-term consequences including infertility, irregular menstrual cycles, obesity, and metabolic disturbances, with long-term risks including cardiovascular diseases and Type 2 diabetes mellitus. Management strategies predominantly involve weight loss interventions alongside pharmacological treatments. This clinical trial proposes the evaluation of traditional Ayurvedic formulations, Varaasanadi Kwatha and Vidanganagaradi Choorna, for their efficacy in managing PCOS. These formulations, are predominantly Kaphamedohara , Katu Tiktha Kashaya rasa pradhana Tikshna guna ,ushna virya and katu vipaka . hold promise in acting as both Sthoulyahara and Arthavapravarthaka. Study design is an Interventional pre- and post-study with a targeted sample size of 28 participants. Eligible female subjects aged 18-45 years, diagnosed with Polycystic Ovarian Syndrome, are recruited from the Outpatient Department of Prasutitantra and Streeroga at the Government Ayurveda College Hospital in Tripunithura. Data collection involves clinical observation using a structured case proforma and conducting relevant investigations. The intervention includes administering 48 ml of Varaasanadi Kwatha twice daily before meals and 6 grams of Vidanganagaradi Choorna with 6 grams of honey as anupana twice daily before meals over a 90-day period. Assessment occurs on the 0th and 91st days, focusing on changes in Body Mass Index, Waist Circumference, ovarian morphology via ultrasound, and PBAC (Pictorial Blood Assessment Chart) score, which evaluates menstrual cycle characteristics. Additionally, participants undergo reviews on the 31st and 61st days, primarily examining changes in Body Mass Index, Waist Circumference, and PBAC score. |