| CTRI Number |
CTRI/2025/02/080197 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Testing the benefits of Finger Millet (Ragi) and Flax Seeds(Atsi) for Women going through Perimenopause |
|
Scientific Title of Study
|
A randomized open labelled controlled Clinical study to evaluate the efficacy of
Finger Millet (Ragi) and Flax Seeds (Atsi) in the
Management of Perimenopausal Syndrome
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kavita |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra |
| Address |
Opd no 2, PG Department of Swasthavritta and Yoga,Institute For Ayurved Studies And Research,Shri Krishna Ayush University Sector 8 Umri Road
Kurukshetra
HARYANA
136118
India |
| Phone |
7988298059 |
| Fax |
|
| Email |
kavitanaik2222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra |
| Address |
Opd no 2, PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7988298059 |
| Fax |
|
| Email |
kavitanaik2222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra |
| Address |
Opd no 2, PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7988298059 |
| Fax |
|
| Email |
kavitanaik2222@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra 136118 Haryana
|
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies and Research Shri Krishna Ayush University Kurukshetra Haryana |
| Address |
Institute For Ayurved Studies & Research, Shri Krishna Ayush University Sector 8 Umri road, Kurukshetra 136118 Haryana India |
| Type of Sponsor |
Other [Government Ayurvedic College] |
|
|
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 Seema Rani |
Institute For Ayurved Studies & Research, Shri Krishna Ayush University Kurukshetra, Haryana |
Opd no 2, PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road
Kurukshetra
Haryana
136118
Kurukshetra
HARYANA |
9466786108
seemaranimd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI KRISHNA AYUSH UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N958||Other specified menopausal and perimenopausal disorders. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: FINGER MILLET(RAGI), Reference: RAJ NIGHANTU (SHALIDHANAYA VARAGA), Route: Oral, Dosage Form: Modaka , Dose: 150(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -MILK), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: FLAX SEEDS (ATSI), Reference: BHAVA PARKASHA NIGHANTU, Route: Oral, Dosage Form: Modaka , Dose: 150(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -MILK), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients having age 35 to 55 years.
2.Patients who are having symptoms of perimenopausal syndrome.
3.Patient who are willing to participate in the trial.
4.Patient who is having osteopenic changes.
|
|
| ExclusionCriteria |
| Details |
1.Known case of carcinoma.
2.Surgical history of menopause i.e.hysterectomy
3.Patient is having mental illness.
4.Patient having diabetes mellitus.
5.Patient is having uncontrolled hypertension,kidney disorder.
6.Patient on prolonged (>6 weeks medication on corticosteroids ,antidepressant, anticholenrgics or any hormone replacement therapy or any other drug therapy that may have any influence on the outcome of study.
7.Patient having history of smoking,alcoholics and drug abusing.
8.Patient having any respiratory issues like asthma,COPD etc.
9.Patient who are not willing to participate in the trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the subjective parameters of Perimenopausal syndrome like hot flushes,
fatigue,pain in joints etc |
follow up for the subjective parameters 1st month, 2nd month, 3rd month and two months after the trial.
Telephonically once a week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of life of patient will be improved.
Improvent in the symptoms of Perimenopausal symptoms. |
follow up for the subjective parameters 1st month, 2nd month, 3rd month and two months after the trial.
Telephonically once a week. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The word menopause is derived from the greek word “mens” for month and “pausis” for cessation. Menopause means permanent cessation of mensuration at the end of reproductive life due to ovarian follicular inactivity. Menopause is divided into two stages perimenopause and post menopause. Perimenopause means around menopause and refers to the time during which the body makes a natural transition to menopause. During this transition, the ovary produce less hormone, causing the menstrual cycle to become erratic or irregular. Climacteric is a transitional phase of weaning of ovarian activity before menopause. Sign and symptoms of this climacteric phase may endure for 6 months to 5 years or even longer. During perimenopause there is gradual decrease in both amount and duration. It may be spotting or delayed and ultimately leads to cessation. Menopause is genetically predetermined .It is not related to the number of pregnancies ,race,socioeconomic education, height, weight ,age at menarche or age at last child birth. In ancient Ayurveda menopause is related with the term Rajonivruti which is also derived from the word Rajah and Nivruti cessation of artava pravurti.According to Acharya Sushruta and various other references 50 years is mentioned as the age of Rajonivruti. when the full body is accompanied by vasomotor ,psychological ,genital locomotor and GIT related symptom.. As we all know diet plays a very major role in prevention of disease in the prevention of disease according to concept of Swasthsya Swastahya Rakshanam which is the primary goal of Ayurveda. Finger millet (Ragi) belonging to the family Poaceace .Ragi contains 30 times much calcium as rice namely 344mg/100 gm which plays a major role in bone development and maintainance as well as in the functioning of nerves and muscle. Finger millet seed coat matter which is a rich source of dietary fibres and phenolic compound were found to exhibit blood glucose and cholesterol lowering and nephroprotective property. Flax seeds (ATSI) is one of the richest source of lignans which are phytoestrogens .These phytoestrogens are present in fibre rich plants like cereals. Flax sseds contains 800 times more lignanas as compared to other food products like legumes. Behaviour of lignans depends upon the biological levels of oestradiol .linseed are rich in omega-3 fatty acids which reduce hypertension and triglycerides level. |