| CTRI Number |
CTRI/2021/07/034951 [Registered on: 19/07/2021] Trial Registered Prospectively |
| Last Modified On: |
19/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to test the safety and effectiveness of combination therapy of 2 Ayurvedic products from Jammi Pharmaceuticals for treating women with PCOS |
|
Scientific Title of Study
|
A PROSPECTIVE, OPEN-LABELLED, PROOF-OF-CONCEPT, COMPARATIVE
CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE
COMBINATION THERAPY OF SUVENTRIS SYRUP AND CYSTEVITTABLETS
COMPARED WITH STANDARD OF CARE IN ADULT WOMEN DIAGNOSED
WITH POLY-CYSTIC OVARIAN SYNDROME |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CS/SRS/APR/21 version 1.0 dated 15 Apr 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemalatha K |
| Designation |
Principal Investigator |
| Affiliation |
Udhbhava Hospital, Ittamadu |
| Address |
Udhbhava Hospital,
Ittamadu, Banashankari 3rd Stage
Bangalore
KARNATAKA
560085
India |
| Phone |
9742797117 |
| Fax |
|
| Email |
crudhbhava01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srivatsa GS |
| Designation |
Managing Director |
| Affiliation |
Samahitha Research Solutions |
| Address |
2nd Floor, Old No. 1204, New No.04 PID No.64-121-04, 26th main road,
9th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560069
India |
| Phone |
6364147989 |
| Fax |
|
| Email |
sri@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Disha Shetty |
| Designation |
Incharge Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
2nd Floor, Old No. 1204, New No.04 PID No.64-121-04, 26th main road,
9th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560069
India |
| Phone |
6364147979 |
| Fax |
|
| Email |
disha@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Jammi Pharmaceuticals Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Jammi Pharmaceuticals Pvt Ltd |
| Address |
121 Jammi Buildings, Royapettah HighRoad, Chennai 600004
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Hemalatha K |
Udhbhava Hospital |
Department of Gynaecology, Udhbhava Hospital, Ittamadu, Banashankari 2nd stage, Bengaluru
Bangalore
KARNATAKA |
9742797117
crudhbhava01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Centre 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: PCOS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CystEvit and Suventris |
CystEvit- 2 tablets- thrice daily after food
Suventris- Syrup- 10ml twice daily after food
Both the interventions work in Tande to reduce the symptoms of PCOS and regularises the menstrual cycle |
| Comparator Agent |
Standard of Care |
Standard of care as prescribed by the Principal investigator |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Young women of age between 18 to 40 yrs. diagnosed withPCOS
2. Sub-fertilefemales
3. Polycystic ovaries with exclusion of otheraetiologies
4. Women with normal uterinecavity
5. Subjects with history of Impaired Glucose Tolerance or Insulin Resistance with PCOS
6. Normal physical activity confirmed with physical and clinical examination, and routine laboratory tests, including AST, ALT, haematology routine urinalysis and measurement of oral temperature and vitalsigns.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactatingwomen.
2. Subjects with presence of infertility factors other thananovulation
3. Subjectswithpelvicorganicpathologies,presenceofotherpathologiessuchasnon- classical congenital adrenal hyperplasia, Cushing’s syndrome and androgen secretingtumours
4. Subjects with thyroid dysfunction, hyperprolactenemia, androgen secreting neoplasia.
5. Women requiring, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs, or other hormonaldrugs.
6. Subjects with any neoplastic, metabolic, and cardiovascular disorder or other concurrent medical illness (i.e., type 1 or type 2 diabetes, renal disease, and mal- absorptivedisorders,acuteandchronicinflammations)confirmedbasedonmedical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count andurinalysis.
7. Subjects with known history of hypersensitivity to the studydrugs.
8. Alcoholic consumers andsmokers
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To evaluate the efficacy of Suventris Syrup and CystEvit Tablet combination therapy when compared to standard of care in eviction of ovarian cysts in subjects diagnosed with Poly-Cystic OvarianSyndrome |
120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To evaluate the number of subjects showing normal ovulation after Suventris Syrup and CystEvit Tablets combination therapy when compared to stand ofcare. |
120 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
19/07/2021 |
| Date of Study Completion (India) |
09/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 commonly known as PCOS is a condition that is common among women of reproductive age. In PCOS many small cysts which are sacs filled with fluids grow inside the ovaries. The common features of PCOS are high levels of the male hormone androgen, irregular periods, lack of ovulation which alters the level of estrogen and progesterone. NDTV health matters on January 5th,2018 reported that 1in 5women in their productive age in India suffer from PCOS. “The exact cause of (PCOS) is unknown. It is a multifactorial metabolic disorder. In this syndrome, a combination of genetics, diet, lifestyle, and environment lead to hormonal disturbances which are responsible for the symptoms of PCOS,†says Dr. Shishta Nadda Basu, Senior Director and Head of Department, Obstetrics and Gynecology & IVF, Max Speciality Hospital, Shalimar Bagh, New Delhi. Apart from irregular periods people with PCOS gain weight, grow facial hair, develop acne, and have infertility issues. Insulin resistance is a common problem in PCOS and if left unchecked can lead to type 2 diabetes. PCOS is diagnosed through an ultrasound or by testing for hormones like follicle-stimulating hormones, estrogen levels, and luteinizing hormones. There is no definitive cure for PCOS in allopathy. The condition is managed by hormone therapy which has uncomfortable side effects.
Ayurveda has the cure for PCOS. Our Ayurvedic formulation CystEvit helps in evicting the cysts from the ovaries and Suventris helps regulate the hormonal balance. Our preliminary study of CystEvit and Suventris has demonstrated that CystEvit reduces the size and number of cysts and ensures ejection of Ova by improving ovulatory function. CystEvit also helps decrease androgenic features like hirsutism, acne, and alopecia.
This study is designed to evaluate the efficacy and safety of Suventris syrup and CystEvit Tablets in adult women diagnosed with Poly-Cystic Ovarian Syndrome. |