| CTRI Number |
CTRI/2021/04/033101 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
08/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial on Women health PCOS conditions |
|
Scientific Title of Study
|
A Prospective, Randomized, Open Label Study to Evaluate the Safety And Efficacy Of Mulmina Orange Amla Ready to Drink as a Supplement In Women With PCOS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/MUL/PCOS/2021 Vesrsion 1.0 dated 01 Mar 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Godavarthi |
| Designation |
C E O |
| Affiliation |
Radiant Research Services Pvt. Ltd |
| Address |
Radiant Research Services Pvt. Ltd #99/A, 8 Main, III Phase Peenya
Industrial Area, Bangalore
Bangalore
Bangalore
KARNATAKA
560058
India |
| Phone |
9880999297 |
| Fax |
|
| Email |
ashok@radiantresearch.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
C E O |
| Affiliation |
Radiant Research Services Pvt. Ltd |
| Address |
Radiant Research Services Pvt. Ltd #99/A, 8 Main, III Phase Peenya
Industrial Area, Bangalore
Bangalore
KARNATAKA
560058
India |
| Phone |
9880999297 |
| Fax |
|
| Email |
ashok@radiantresearch.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Raghavendra K V |
| Designation |
General Manager-Marketing |
| Affiliation |
Jagdale industries pvt. Ltd |
| Address |
Jagdale industries pvt. Ltd No 782, 15th Cross, I Phase, J.P.Nagar,
Bangalore - 560 0078. Karnataka, INDIA Bangalore
Bangalore
Bangalore
KARNATAKA
560 0078
India |
| Phone |
9845345469 |
| Fax |
|
| Email |
raghavendrakv16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jagdale industries pvt. Ltd 782, 15th Cross, I Phase, J.P.Nagar, Bangalore - 560 0078.
Karnataka, INDIA |
|
|
Primary Sponsor
|
| Name |
Jagdale industries pvt Ltd |
| Address |
782, 15th Cross, I Phase, J.P.Nagar, Bangalore - 560 0078. Karnataka, INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSavitha C |
Bangalore Medical College and Research Institute |
Room No:2 1st floor
Fort, Victoria campus Krishna Rajendra
Rd, Bengaluru,
Karnataka 560002
Bangalore
KARNATAKA
Bangalore
Bangalore
KARNATAKA |
9448292424
savithadr1979@gmail.com |
| Dr Prathibha S D |
Dr. B.R. Ambedkar Medical College & Hospital |
Ground floor room no 3
No 24 Shampura Main
Road,
Kadugondanahalli
Bengaluru, Karnataka
560045
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9448739793
prathibhasd67@gmail.com |
| Dr Shubarani |
Sushrutha Ayurvedic Medical College And Hospital |
Block no 1 Prashanti Kuteera jodi Bingipura,
Jigani Hobli, AnekalTaluk, Bengaluru,
Karnataka 560105
Bangalore
KARNATAKA |
9449453674
dr.shubharani111@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics commitee-Bangalore Medical College and Research Institute |
Approved |
| Ethics committee-Dr.B. R.Ambedkar Medical College |
Submittted/Under Review |
| Sri Venkateshwara Hospitals Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PCOS |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: Raktapradar, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mulmina Amla Orange ready to drink |
Dose: 200ml drink Dosage form:
Oral Drink Frequency : 2 packs
per day for 4 weeks Route of
administrate : Orally |
| Comparator Agent |
Standard of Care recommended
by Investigator |
As per principal investigator
recommendations |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
i. Female volunteer aged more than 18 years
ii. Women with mild PCOS related complications
iii. Willing to give written consent to participate
|
|
| ExclusionCriteria |
| Details |
1. Patients with preexisting severe systemic disease necessitating long term medication.
2. Patients with known history of diabetes mellitus.
3. Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation.
4. History of cancer including solid tumors hematologic malignancies and carcinoma in situ
5. Any neurological congenital or acquired vascular or systemic disorder which could affect any of the efficacy assessments.
6. Participation in the current or previous treatment with any approved or investigational health supplements during the past 1 month.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall improvement in the PCOD condition from baseline |
Day 0, 14 and 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General health and adverse events |
Day 0 to Day 28 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/04/2021 |
| Date of Study Completion (India) |
13/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
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
|
A Herbal Immune Boosting and Anti-oxidant
drinks for wellness with particular emphasis as a health promoter. The
formulation is meant for general health and well-being with the herbs concerned
acting synergistically to provide an immune boosting properties and high
anti-oxidant benefit without any attenuating side-effects. Cardinal to the
invention is the synergistic play between the natural ingredients and
Meso-nutrients which provide an Immune Boosting Activity and rich Anti-oxidant
through its higher ORAC values.
Wellness drink Mulmina
Amla Orange wherein
the herbs, fruit extract and fortifying agents act synergistically to provide a
rich Meso-nutrients contributing Antioxidant and Immune Boosting Property
through its high ORAC values. The said beverage is formulated with a carefully chosen
herbs–that are meant to act as anti-inflammatory, immune-boosting and
free-radical scavenging agents. The herbs so formulated is combined with a
healthy vitamin and mineral rich, anti-oxidant fruit juices and is fortified
with the necessary vitamins and minerals to result in a very tasty drink for
good health. The taste factor makes the herbal concoction palatable and hence
ensure compliance. Hence this preparation has all the three categories of
nutrients namely Macro-nutrients (Carbohydrates, Protein, Dietary Fibres etc),
Micro Nutrients (Vitamins and Minerals), which are required for the body to
perform wellness. Another uniqueness of the formulation i.e. Tetrapak
technology, This is known all over world for its aseptic technology, Product is
packed in Cylindrical Tetra Brick pack which will not come in contact with any
external environmental conditions. Filled in automatic machines with form –
Fill - Seal concept in aseptic conditions known to preserve its product
properties and ensures longer shelf life of 12months |