| CTRI Number |
CTRI/2021/02/030954 [Registered on: 03/02/2021] Trial Registered Prospectively |
| Last Modified On: |
23/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MANAGEMENT OF ARTAVA DUSHTI W.S.R TO POLYCYSTIC OVARIAN SYNDROME WITH AROGYAVARDHINI RASA AND PATHADI CHOORNA. |
|
Scientific Title of Study
|
Management of Artava dushti w.s.r to Polycystic ovarian syndrome with Arogyavardhini rasa and Pathadi choorna: A single arm open labelled clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijila V |
| Designation |
MS Scholar |
| Affiliation |
IPGT AND RA |
| Address |
Department of Prasutitantra evam streeroga,5th floor,Ipgt and ra,Jamnagar-361008 ,Gujarat.
Jamnagar
GUJARAT
361008
India |
| Phone |
06282912590 |
| Fax |
|
| Email |
vijilavimal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Laxmipriya dei |
| Designation |
Professor -Hod department of PTSR |
| Affiliation |
IPGT AND RA |
| Address |
Department of Prasutitantra evam streeroga,5th floor,Ipgt and ra,Jamnagar-361008 ,Gujarat.
Jamnagar
GUJARAT
361008
India |
| Phone |
9228198366 |
| Fax |
|
| Email |
deilaxmipriya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Laxmipriya dei |
| Designation |
Professor -Hod department of PTSR |
| Affiliation |
IPGT AND RA |
| Address |
Department of Prasutitantra evam streeroga,5th floor,Ipgt and ra,Jamnagar-361008 ,Gujarat.
Jamnagar
GUJARAT
361008
India |
| Phone |
9228198366 |
| Fax |
|
| Email |
deilaxmipriya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| IPGT AND RA ,Gujarat ayurved university,Jamnagar -361008 |
|
|
Primary Sponsor
|
| Name |
IPGT AND RA |
| Address |
IPGT AND RA , Jamnagar, 361008,Gujarat. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Laxmipriya dei |
PG Hospital Ipgt and ra |
PG hospital ,Department of Prasutitantra evam streeroga,Ipgt and ra,Jamnagar 361008, Gujarat
Jamnagar
GUJARAT |
9228198366
deilaxmipriya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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: ARTAVADUSHTI, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arogyavardhini rasa and
pathadi choorna |
Arogyavardhini rasa 250 mg along with Pathadi choorna 5gm given orally on empty stomach both morning and evening with lukewarm water for a period of 3 months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Both married /unmarried patients in the age group of 18-40yrs.
Patients with any 3 or more clinical features of PCOS like-
Amenorrhea or Oligomenorrhoea
Anovulation
Infertility (Due to anovulation)
Acne
Hirsutism (Ferriman-Gallwey scale)
Obesity (BMI above 25)
Acanthosis nigricans
Along with confirmation of any one Polycystic Ovary in USG finding.
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from Pelvic/Systemic diseases like (Endometriosis, Hydrosalpinx, Fibroid uterus,).
2. Organic lesions of reproductive tract like T.B, Carcinoma and Congenital deformities.
3. Patients with history of Cardiac diseases, Chronic liver disease.
4. Age group <18yrs and > 40yrs will be excluded.
5. Uncontrolled Hypertension (Systolic BP above 150 & Diastolic above100mmhg), Uncontrol led Diabetes mellitus (above the range of 160-200 mg/dl, FBS)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that trial drug help to improve anovulation ,oligoovulation ,hirsutism ,amenorrhea ,acne ,infertility, obesity |
4 weeks after completion of clinical trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Drug may have effect on ovulation induction and conception. |
After the followup period. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
10/02/2021 |
| 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
|
Nil |
|
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
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - For the Dissertation work of the institute
- For how long will this data be available start date provided 03-06-2022 and end date provided 03-06-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study comprises a clinical trial for the management of Artavadushti w.s.r to Polycystic Ovarian Syndrome with Arogyavardhini Rasa and Pathadi choorna .Polycystic ovarian syndrome is a heterogenous multisystem endocrinological disorder in women of reproductive age with ovarian expression of various metabolic disturbances and wide spectrum of clinical features such as obesity, menstrual abnormalities and hyperandrogenism. Women often initiate treatments for a cluster of symptoms like menstrual irregularities, obesity, hirsutism. But the most concerning medical consequences include, Infertility, Diabetes mellitus, Endometrial carcinoma, Hypertension, Cardiovascular disease. No permanent effective treatment is found for PCOS in modern therapy except some sort of OCP, Metformin etc and for ovulation induction drugs like Letrozole are used along with symptomatic management. Moreover, it may fail in preventing the long-term consequences of PCOS. Ayurveda provides ample of medicines and treatment protocol under the concept of Ashta Artava Duhsti.Main objectives of this study is to evaluate the effect of trial drugs Arogyavardhini Rasa and Pathadi Choorna in the management of PCOS and efficacy on ovulation and conception . Here 60 diagnosed patients of PCOS as per Rotterdam revised criteria 2004 will be registered.Patients administerded with Arogyavardhini Rasa 250mg and Pathadi Choorna 5gm along with water on empty stomach both morning and evening for a period of 3 months . After that there will be a followup for1 month. A specific scoring pattern will develop based on clinical features of PCOS and the assessment will be done on the basis of both subjective & objective parameters.All the outcomes will be noted and appropriate statistical test applied to find the effect.
· |