| CTRI Number |
CTRI/2019/11/022183 [Registered on: 27/11/2019] Trial Registered Prospectively |
| Last Modified On: |
10/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Ayuvita Forte Capsule in irregular periods with cysts in ovary. |
|
Scientific Title of Study
|
An Open Label, Multi-center, Prospective Clinical study to Evaluate Efficacy and Safety of Ayuvita Capsule in patients suffering from PCOS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AYVTA/PCOS/WELX/2019, Version 1.0, 04th Oct 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul R Kamde |
| Designation |
Assistant Professor and HOD |
| Affiliation |
KVTR Ayurved College Boradi |
| Address |
Department of Prasuti Tantra and Streeroga Ground Floor OPD No 1 KVTR Ayurved College Boradi Tal Shirpur Dist Dhule
Dhule
MAHARASHTRA
425428
India |
| Phone |
9422815205 |
| Fax |
|
| Email |
kamderahul77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
A wing 402-A, B, C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
A wing 402-A, B, C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Welex laboratories Pvt. Ltd, 1002, Marathon Innova Nextgen, Off Ganpatrao kadam marg, Lower Parel, Mumbai -13. |
|
|
Primary Sponsor
|
| Name |
Welex Laboratories Pvt Ltd |
| Address |
1002, Marathon Innova Nextgen, Off Ganpatrao kadam marg, Lower Parel, Mumbai -13. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Geetanjali Vaidya |
Ayurved Seva Sangh’s Ayurved Mahavidyalaya |
Department of Prasuti Tantra and Streeroga Ground Floor OPD no 5 Ayurved Seva Sangh’s Ayurved Mahavidyalaya Ganeshwadi Panchvati Nashik 422003
Phone-
Email ID:-
Nashik
MAHARASHTRA |
8975381328
geetanjalivaidya28@gmail.com |
| Dr Rahul R Kamde |
KVTR Ayurvedic College |
Department of Prasuti Tantra and Streeroga Ground Floor OPD no 1 KVTR Ayurved College Boradi Tal Shirpur Dist Dhule 425428
Dhule
MAHARASHTRA |
9422815205
kamderahul77@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ayurved seva sangh Ayurved Mahavidyalaya, Nashik |
Approved |
| Institutional Ethics Committee, KVTR Ayurvedic College, Boradi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ayuvita Forte Capsules |
contains Mucuna pruriens, Saraca indica, Symplocos paniculat, Glycyrrhiza glabra, Sida cordifoli, Withania somnifera, Asparagus racemosus, Asparagus adscendens, Emblica officinale, Tinospora cordifolia, Mandura Bhasma, Pueraria tuberose, Leptadenia reticulate, Convolvulus pluricauli, Mesua ferrea, Commiphora myrrha
Dosage and Treatment Duration: 2 Capsules twice daily orally after meals with water for 180 days.
|
| Comparator Agent |
NIL |
NIL
Dosage and Treatment Duration: NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects diagnosed with PCOS by ppresence of two of the of the three Rotterdam criteria: Oligomenorrhea, anovulation; Hyperandrogenism; and the observation of polycystic ovaries by USG of the Lower Abdomen and Pelvis.
2.Subjects willing to follow the procedures as per the study protocol and
voluntarily signing informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids, endometriosis, cervical erosion (as diagnosed by USG lower abdomen and pelvis).
2. Subjects having clinical and/or biochemical signs of severe hyperandronism
3. Subjects having systematic illness like uncontrolled hypertension, uncontrolled diabetes mellitus, renal disease, tuberculosis, liver disorder, coagulation disorder, hypothyroidism, hyperthyroidism, Hirsutism, Addison’s disease and/or Cushing disease.
4. Subjects with one year of history of child birth
5. History of genitor-urinary surgery, and/or other major medical or surgical diseases; which can affect or related with study outcomes.
6. Nursing, pregnant or lactating women.
7. Use of corticosteroids or hormones or hormonal drugs within last 1 months of screening visit.
8. Use of any other investigational drug within 1 month prior to screening visit.
9. Patient having known hypersensitivity to any ingredient of the study drug.
10. Pregnant and Lactating females.
11. Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Number of subjects achieving ovulation.
2. Number of subjects achieving regular menstruation
|
day -7, day 0, day 30, day 60, day 90, day 120, day 150 and day 180
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in Testosterone.
2.Change in polycystic ovary as observed in the USG.
3.Changes LH, FSH, Progesterone, Estrogen
4.Changes in HbA1c, Blood sugar F and PP and Serum Insulin
5.Global assessment for overall change by subject and investigator at the end of study treatment.
6.Tolerability of study drug
7.Adverse events
8.Changes in laboratory parameters
|
day -7, day 0, day 30, day 60, day 90, day 120, day 150 and day 180
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/12/2019 |
| Date of Study Completion (India) |
10/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It was an open label, multi-center, prospective, clinical study to evaluate efficacy and safety of Ayuvita Forte Capsule in patients suffering from PCOS. The study was conducted in 30 female subjects at two centers in India. Subjects were asked to consume 2 Ayuvita Forte Capsules twice daily orally after meals with water for 180 days. The primary objective of the study was to assess number of subjects achieving ovulation and number of subjects achieving regular menstruation. The secondary objectives of the study were to assess changes in serum testosterone, change in polycystic ovary as observed in the USG, changes LH, FSH, Progesterone, Estrogen, changes in HbA1c, Blood sugar F and PP and Serum Insulin, global assessment for overall change by subject and investigator at the end of study treatment, tolerability of study drug, adverse events and changes in laboratory parameters.
Summary of Results:
The results of the study conclude that Ayuvita Forte Capsules were found to be effective in regularising menstrual cycles and resolve Poly Cystic Ovarian condition as observed in Ultrasonography. Ayuvita capsules also helped in achieving ovulation and has the potential to treat infertility. Ayuvita capsules were found to be safe without causing any adverse effects even on long term consumption of 6 months. Further randomised comparative clinical study with larger sample size will help to establish and validate the results of the present study. |