| CTRI Number |
CTRI/2025/12/099019 [Registered on: 12/12/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Cyperus rotundus extract (Cirpusins®) as a supplement for weight management and Post Menopausal Syndrome (PMS) in female population. |
Scientific Title of Study
Modification(s)
|
A randomized, double-blind, placebo-controlled clinical study to
evaluate the efficacy and safety of Cyperus rotundus extract
(Cirpusins®) for weight management and Post Menopausal Syndrome
(PMS). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SSGL_CRD/135/CIRP_Wt_PMS/I/APR/25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahalakshmi Pendurthi |
| Designation |
principal Investigator |
| Affiliation |
Medwell Multi Speciality Hospital |
| Address |
Medwell Multi Speciality Hospital 65 23 Parinitha Arcade Kudlu main road beside Mobicom Parappana AgraharaMainRd beside bata showroom Electronic City Bengaluru Karnataka 560100
65 23 Parinitha Arcade Kudlu main road beside Mobicom Parappana AgraharaMainRd beside bata showroom Electronic City Bengaluru Karnataka 560100
Bangalore
KARNATAKA
560100
India |
| Phone |
9573787482 |
| Fax |
|
| Email |
drmahapendurthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satish G |
| Designation |
VicePresident |
| Affiliation |
Sami-Sabinsa Group Limited |
| Address |
Sami Sabinsa Group Limited 19 1 19 2 first Main second Phase Peenya Industrial Area
Bangalore
KARNATAKA
560058
India
19 1 19 2 first Main second Phase Peenya Industrial Area Bangalore.
Bangalore
KARNATAKA
560058
India
Bangalore
KARNATAKA
560058
India |
| Phone |
08068527777 |
| Fax |
|
| Email |
satish.g@sami -sabinsagroup.com |
|
Details of Contact Person
Public Query
|
| Name |
Satish G |
| Designation |
VicePresident |
| Affiliation |
Sami-Sabinsa Group Limited |
| Address |
Sami Sabinsa Group Limited 19 1 19 2 first Main second Phase Peenya Industrial Area
Bangalore
KARNATAKA
560058
India
19 1 19 2 first Main second Phase Peenya Industrial Area Bangalore.
Bangalore
KARNATAKA
560058
India
Bangalore
KARNATAKA
560058
India |
| Phone |
08068527777 |
| Fax |
|
| Email |
satish.g@sami -sabinsagroup.com |
|
|
Source of Monetary or Material Support
|
| Sami -Sabinsa Group Limited 19 1 19 2 first Main second Phase, Peenya Industrial Area Bangalore
Karnataka560058 |
|
|
Primary Sponsor
|
| Name |
SamiSabinsa Group Limited |
| Address |
19 1 19 2 first Main second Phase peenya Industrial Area Bangalore. |
| Type of Sponsor |
Other [Manufactures markets phytonutrients standardized herbal extracts nutritional supplements] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMahalakshmi Pendurthi |
Medwell MultiSpeciality Hospital |
OPD 2 65/23 Parinitha Arcade Kudlu main road beside Mobicom Parappana AgraharaMainRd beside bata showroom Electronic City Bengaluru Karnataka 560100
Bangalore
KARNATAKA |
9573787482
drmahapendurthi@gmail.com |
| DrV NarayanaSwamy |
Vagus Super Speciality Hospital |
7,8and 4th Main,18th Cross, Malleshwaram,Bengaluru-560055
Bangalore
KARNATAKA |
9448053952
drnarayanaswamy@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics committee |
Approved |
| VagusInstitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N951||Menopausal and female climactericstates, (2) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cirpusins® |
Cirpusins® 250mg + BioPerine® 5mg
Twice a day after food |
| Comparator Agent |
Placebo |
Microcrystalline Cellulose 250 mg
Twice a day after food |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Participants must provide a voluntarily written and signed ICF to be screened & enrolled in the study.
2. Participant must be a clinically confirmed post-menopausal women in the age group of 45 to 65 years both inclusive.
3. Must be overweight obese with a body mass index BMI between 25 to 34.9 kg m2 both inclusive.
4. Any Case of self-reported post-menopausal symptoms for the past 3 months like
• Vasomotor symptoms (hot flashes night sweats sweating.
• Psychosocial (anxiety depression irritability loneliness
• Physical (flatulence or gas pains aching in muscle or joints insomnia decrease in physical strength weight gain frequent urination.
• Sexual (mood changes, vaginal atrophy
5. Participants with MRS severity range from moderate 9to15 to severe 16.
6. Individuals must be in good health with controlled diabetes and hypertension with medications, but without thyroid disease.
7. Participants must be able to consume the investigational product as per the protocol throughout the study period.
8. Have normal vital signs or within clinically acceptable range as considered by the Principal Investigator at the time of screening and follow-up visits.
9. Must not have taken any treatment for PMS and agree to refrain from any other treatments for post-menopause symptoms during the study period.
10. Willing to abide by the protocol and all study related procedures from the beginning till the end of the study. |
|
| ExclusionCriteria |
| Details |
Induced menopause through surgery such as bilateral oophorectomy or salpingooophorectomy chemotherapy radiation or drugs.
2. Individuals who had undergone a partial or total hysterectomy.
3. Use of any treatment for post-menopausal symptoms.
4. Have a known sensitivity, intolerability or allergy to any of the study products or their excipients.
5. Have a positive medical history of heart disease, renal disease hepatic impairment or active systemic infection.
6. Have uncontrolled high blood pressure greater than160 mmHg systolic or more than or equal to110 mmHg diastolic or thyroid disease despite taking regular medication for the last three months at the time of screening and enrolment.
7. Have Type I or uncontrolled Type 2 diabetes HbA1c morethan 9.5.
8. Use of any weight loss medication, special diets or supplements.
9. History of cancer.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the efficacy of Cyperus rotundus extract in the management of body weight and improvement in quality of life using Menopausal Rating Scale (MRS) in women after menopause
2. To evaluate the efficacy of Cyperus rotundus extract in the management of body weight and improvement in quality of life using Menopausal Rating Scale MRS in women after menopause |
1. from Day 1 to 91 days
2. from Day 1 to 91 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean change in BMI & anthropometric measurements hip waist & hip waist ratio.
2. Mean change in Lipid profile .
3. Mean change in Serum hormone levels (FSH, LH Estradiol Progesterone Testosterone
4. Incidence of any AE SAE during the study period.
5. Any abnormal change in the lab results. |
1. from Day 1 to 91 days
2.from Day 1 to 91days
3. from Day 1 to 91 days
4. from Day 1 to 91 days
5. from Day 1 to 91 days |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/01/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
this clinical study a randomized double-blind placebo controlled trial to evaluate the efficacy and safety of Cyperus rotundus extract Cirpusins® for weight management and post menopausal syndrome PMS. This study aims to provide robust evidence on the potential benefits and safety of Cyperus rotundus in weight management for postmenopausal women
Secondary Endpoints includes
Mean change in Lipid profile from the beginning till the end of the study. Mean change in Serum hormone levels FSH LH Estradiol Progesterone Testosterone from Day 1 to Day 91. Incidence of any AE SAE during the study period. · |