| CTRI Number |
CTRI/2025/07/090117 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical efficacy of Ashokarishtam, AYUSH SR, and Praval Pishti in the management of Menopausal syndrome (Rajonivrittti Lakshan) : A Prospective Randomized Open Label Standard Control Trial |
|
Scientific Title of Study
|
Clinical efficacy of Ashokarishtam, AYUSH SR, and Praval Pishti in the management of Menopausal syndrome (Rajonivrittti Lakshan) : A Prospective Randomized Open Label Standard Control Trial |
| 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 Monika |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
reserach officer Ayu |
| Address |
M.S regional Ayurveda research institute Jaipur
M S regional Ayurveda research institute Banipark Jaipur
Jaipur
RAJASTHAN
302016
India |
| Phone |
7976470062 |
| Fax |
|
| Email |
monika@ccras.nic.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
MSRARI, Jaipur |
| Address |
MSRARI
Indira colony, bani park, jhotwara road
Jaipur
RAJASTHAN
302016
India |
| Phone |
7976470062 |
| Fax |
|
| Email |
monika@ccras.nic.in |
|
Details of Contact Person
Public Query
|
| Name |
DR BANI RAM MEENA |
| Designation |
ASSIST DIRECTOR INCHARGE |
| Affiliation |
MSRARI, Jaipur |
| Address |
MSRARI
Indira colony, bani park, jhotwara road
Jaipur
RAJASTHAN
302016
India |
| Phone |
8949930250 |
| Fax |
|
| Email |
acri.jaipur@gmail.com |
|
|
Source of Monetary or Material Support
|
| CCRAS MINISTRY OF AYUSH, opposite D block Janakpuri NEW DELHI 110058 |
|
|
Primary Sponsor
|
| Name |
CCRAS |
| Address |
CCRAS MINISTRY OF AYUSH GOVT OF INDIA opposite D block Janakpuri NEW DELHI 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Monika |
MS Regional Ayurveda Research Institute |
room number 11B
Indira colon bani park Jaipur
Jaipur
RAJASTHAN |
07597117008
monika@ccras.nic.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF MSRARI |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE OF MSRARI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N951||Menopausal and female climactericstates. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ASHOKARISHTAM, Reference: API Part 2, Volume 2, page 10, Route: Oral, Dosage Form: Arishta, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: WATER), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PRAVAL PISHTI, Reference: AFI Part 1 pag223, Route: Oral, Dosage Form: Pishti, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: MILK), Additional Information: - | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: AYUSH SR, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: MILK), Additional Information: - | | 4 | Comparator Arm (Non Ayurveda) | | - | TIBOLONE | TIBOLONE 2.5MG OD AFTER MEALS FOR THREE MONTHS |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
i. Patient with with amenorrhea of more than or equal to 12 months
ii. Kuperman menopausal index score Of ore than or equal to 15
iii. Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Patients with age less 40 years and more 55 years
2. Level of FSH less than 25.8 IU/L
3. Endometrial thickness more than 5mm
4. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT more than 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine more than 1.2mg/dl)
5. uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease
6. Patients with endocrine disorders (hypothyroidism Hyperthyroidism hyperparathyroidism Untreated Cushing‘s syndrome
7. Patients with poorly controlled Hypertension ( more than 160 / 100 mm Hg)
8. Patients who are consuming any drug which is known to affect bone metabolism such as SERMs, bisphosphonates, calcitonin, Vit D (more than 60,000 units) and corticosteroids.
9. Patients with Diabetes Mellitus, Rheumatoid arthritis, Coronary Heart disease
10. Alcoholics and/or drug abusers for more than 3 months, methotrexate anti-convulsants diuretics etc
11. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
12. H/o hypersensitivity to any of the trial drugs or their ingredients
13. Patients who have completed participation in any other clinical trial during the past six months.Any other condition that the investigator thinks may jeopardise the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Menopausal symptoms using menopause Rating scale (MRS) |
at base line, 14th day, 28th day, 42nd 56th , 70th day ,84th day and 112th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in Quality of Life index (QOL) using the MENQOL questionnaire & Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) Questionnaire
Changes in hematological & biological parameters viz CBC LFT lipid profile KFT serum calcium FSH LH Estradiol
Changes in parameters including biomarkers of bone health viz Bone specific alkaline phosphatase SERUM calcium X-ray Lumbosacral spine BMD |
base line 28th 56th 84th day 112th day
At baseline 84th day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 |
|
Date of First Enrollment (India)
|
14/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [monika@ccras.nic.in].
- For how long will this data be available start date provided 01-04-2028 and end date provided 01-04-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Menopause is mainly characterized by permanent cessation of menstruation for more than 12 months. Hormone Replacement Therapy (HRT) prescribed by Modern science carries potential risks such as breast cancer endometrial cancer ovarian cancer stroke etc Hence needs careful assessment and evaluation of each individual. In Ayurveda, menopause is considered under Jara vyadhi. There is a potential scope for Rasayan therapy in managing menopausal syndrome. Preferably vata pacifying rasayan drugs should be used in menopause. These agents act at the level of rasa by improving the nutritional value of poshakrasa (nutritive fluids), which helps to obtain the best quality of body tissues (dhatus). Therefore, among various rasayan drugs Ashokarishtam, Ayush SR, and Praval Pishti were selected along with standard control in the management of Menopausal syndrome (Rajonivrittti Lakshan. Hence the study aims to assess the clinical efficacy of Ashokarishtam, Ayush SR, and Praval Pishti in the management of Menopausal syndrome (Rajonivrittti Lakshan) |