CTRI

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CTRI Number

CTRI/2024/12/077783 [Registered on: 06/12/2024] Trial Registered Prospectively

Last Modified On:

03/12/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Yoga & Naturopathy
Diagnostic
Preventive

Study Design

Randomized, Parallel Group Trial

Public Title of Study

To evaluate the role of Ayurvedic medicine and lifestyle in management of post-menopausal women

Scientific Title of Study

To evaluate the role of Ayurvedic medicine and lifestyle in management of post-menopausal women

Trial Acronym

PM-01

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Garima Kachhawa
Designation	Professor
Affiliation	All India Institute of Medical Sciences, New Delhi
Address	Room Number-701, 7th floor, MCH Block, AIIMS,New Delhi-110029 New Delhi DELHI 110029 India
Phone	09868246702
Fax
Email	garimakachhawa2012@gmail.com

Details of Contact Person
Scientific Query

Name	Dr GARIMA KACHHAWA
Designation	Professor
Affiliation	All India Institute of Medical Sciences, New Delhi
Address	Room Number-701, 7th floor, MCH block, AIIMS, New Delhi-110029 DELHI 110029 India
Phone	09868246702
Fax
Email	garimakachhawa2012@gmail.com

Details of Contact Person
Public Query

Name	Dr Garima Kachhawa
Designation	Professor
Affiliation	All India Institute of Medical Sciences, New Delhi
Address	Room Number-701, 7th floor, MCH Block, AIIMS, New Delhi-110029 New Delhi DELHI 110029 India
Phone	09868246702
Fax
Email	garimakachhawa2012@gmail.com

Source of Monetary or Material Support

ICMR,NEW DELHI

Primary Sponsor

Name	INDIAN COUNCIL OF MEDICAL RESEARCH
Address	ICMR, ANSARI NAGAR, NEW DELHI
Type of Sponsor	Government funding agency

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Garima Kachhawa	AIIMS, New Delhi	Room Number-701, 7th floor, MCH Block, AIIMS, New Delhi-110029 New Delhi DELHI	09868246702 garimakachhawa2012@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institute Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E349\|\|Endocrine disorder, unspecified. Ayurveda Condition: RAJONASAHÂ (KEVALAVATA), (2) ICD-10 Condition:E349\|\|Endocrine disorder, unspecified. Ayurveda Condition: RAJONASAHÂ (KEVALAVATA),

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Mukta shukti-pishti, Reference: Ayurveda, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 6 Months, Reference: No, Route: NA, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2	Comparator Arm (Non Ayurveda)		-	Standard Treatment (Tab Calcium 500 mg BD))	Group II: Standard treatment and physical activity plan (home-based mild-moderate exercise and walking for 15-45 minutes)
3	Intervention Arm	Drug	Classical		(1) Medicine Name: Shatawari churn , Reference: Ayurveda, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 6(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 6 Months, Reference: , Route: , Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: 6 Months, Reference: , Route: , Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:

Inclusion Criteria

Age From	45.00 Year(s)
Age To	65.00 Year(s)
Gender	Female
Details	1. Postmenopausal women aged 45 to 65 years 2. Postmenopausal women with natural, induced or surgical menopause 3. Willing to participate in the study

ExclusionCriteria

Details

1. Women with T score less than -2.5 of BMD
2. Women with severe menopausal symptoms including stroke, cardiovascular diseases requiring pharmacological treatment
3. Chronic comorbidities requiring treatment
4. Any condition preventing walking/exercise
5. Not willing for follow-up
6. Any condition on PI discretion

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Alternation

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
1. We expect from this study that the cure rate of menopausal symptoms with Ayurvedic therapies is comparable to standard non-hormonal treatment.	3,6 and 12 months

Secondary Outcome

Outcome	TimePoints
1. The study will provide us the acceptability of Ayurvedic treatment & Yoga for menopausal symptoms. 2. We will find out the prevalence of various menopausal symptoms, NCD, osteoporosis & risk factors for CVD in Indian menopausal women. 3. We will find out the level of various inflammatory markers (NLR, PLR & CRP) in Indian menopausal women.	0,3,6 & 12 months

Target Sample Size

Total Sample Size="250"
Sample Size from India="250"
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

Post Marketing Surveillance

Date of First Enrollment (India)

01/03/2025

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="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Open to Recruitment

Recruitment Status of Trial (India)

Open to Recruitment

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

i. Rationale/Gaps in existing knowledge: Menopause is an important milestone in a womanâ€™s life when she experiences a variety of physical, psychosocial and sexual symptoms. Many of these women have existing NCD which precludes use of MHT. Presently there are only a few effective options for menopausal symptoms in women who are reluctant to use MHT or MHT is contraindicated. There is a need to explore various non-hormonal therapies to treat menopausal symptoms. Ayurvedic therapies remain unexplored to address this issue.

ii. Novelty: To compare ayurvedic medicine and Yoga with standard treatment and physical activity plan using RCT is a novel concept.

iii. Objectives: This study will evaluate efficacy of oral Ayurvedic medicine (Shatawari churn 6 gm twice daily and Mukta shukti-pishti 250 mg twice daily) and Yoga in control of menopausal symptoms in women aged 45-65 years as compared to standard treatment and physical activity plan. It will also assess acceptance and compliance of women to Ayurvedic therapies.

iv. Methods: This study will recruit a total of 250 postmenopausal women aged 45-65 years who will be assessed for menopausal symptoms using SF-36 questionnaire. All women will undergo screening for NCD, osteoporosis, breast and cervical cancer. Women will be randomized (1:1) into two groups. Group 1 will receive Ayurvedic medicines and Yoga for 6 months and Group 2 will receive standard treatment and physical activity plan as per hospital protocol. Follow-up will be at 1, 3, 6 and 12-months.

v. Expected Outcome: Ayurvedic treatment and Yoga is non-inferior to standard treatment and physical activity plan in the management of menopausal symptoms.