CTRI

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CTRI Number

CTRI/2025/03/082576 [Registered on: 18/03/2025] Trial Registered Prospectively

Last Modified On:

17/03/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Effect of Gambhari phala Churna after permanent stoppage of menses .

Scientific Title of Study

An Open Randomised Controlled Clinical study to evaluate the Efficacy of Gambhari phal churna with Godugdha in Rajonivritti lakshanas w.s.r. to Post Menopausal 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 Akanksha Ramesh Salunkhe
Designation	PG Student Prasutitantra and Streeroga
Affiliation	Yashwant Ayurvedic College Post Graduate Training and Research centre Kodoli
Address	Department of Prasutitantra Evum Streeroga ,Opd no 8 Yashwant Ayurvedic College Post graduate training and Research centre Kodoli, District Kolhapur Kolhapur MAHARASHTRA 416114 India
Phone	9404254059
Fax
Email	arsalunkhe98@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Vishala Turlapati
Designation	Guide ,HOD and Professor
Affiliation	Yashwant Ayurvedic College Post Graduate Training and Research centre Kodoli
Address	Department of Prasutitantra evum Streeroga Opd no 8 Yashwant Ayurvedic College Post graduate training and Research centre Kodoli, District Kolhapur Kolhapur MAHARASHTRA 416114 India
Phone	9960217429
Fax
Email	vishalaturlapati@gmail.com

Details of Contact Person
Public Query

Name	Dr Akanksha Ramesh Salunkhe
Designation	PG Student Prasutitantra and Streeroga Department
Affiliation	Yashwant Ayurvedic College Post Graduate Training and Research centre Kodoli
Address	Department of Prasutitantra Evum Streeroga , Opd no. 8 Yashwant Ayurvedic College Post graduate training and Research centre Kodoli, District Kolhapur Kolhapur MAHARASHTRA 416114 India
Phone	9404254059
Fax
Email	arsalunkhe98@gmail.com

Source of Monetary or Material Support

Yashwant Ayurvedic College Post graduate Training and Research Centre Kodoli, Tal- Panhala District- Kolhapur State- Maharashtra Country-India Pincode-416114

Primary Sponsor

Name	Dr Akanksha Ramesh Salunkhe
Address	Yashwant Ayurvedic College Post Graduate training and Research centre, Kodoli Tal - Panhala District- Kolhapur State- Maharashtra Country- India Pincode -416114
Type of Sponsor	Other [Self]

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 Akanksha Ramesh Salunkhe	Yashwant Ayurvedic College Postgraduate training and Research centre Kodoli	OPD No .8 and 15 of Prasutitantra Evum Streeroga department Kolhapur MAHARASHTRA	9404254059 arsalunkhe98@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Comittee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E00-E89\|\|Endocrine, nutritional and metabolic diseases. Ayurveda Condition: RAJONASAH (KEVALAVATA),

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Gambhari phal , Reference: Bhavprakash Nighantu Guducyadivarga 4,Sushrut Sutrasthan 46/184, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Godugdha ), Additional Information: Gambhari phal churn 3 gm in three divided doses with Godugdh thrice a day after food.
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Yashtimadhu , Reference: Bhavprakash Nighantu Haritakyadivarga 43, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Godugdha ), Additional Information: Yashtimadhu churna 3 gm in three divided doses with Godugdh thrice a day after food

Inclusion Criteria

Age From	45.00 Year(s)
Age To	55.00 Year(s)
Gender	Female
Details	1. Patients having the Postmenopausal Symptoms will be selected 2. Patient who underwent Panhysterectomy with clinical features of menopausal Symptoms 3.Patients in Rajonivritti who have attained menopause 1 year back

ExclusionCriteria

Details

1. Patient with known history of cardiovascular disease and symptoms.

2. Patient with prolonged medication like corticosteroids, Antidepressants and HRT that may influence outcome of study.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To evaluate the Efficacy of Gambhari Phal Churna with Godugdha in Rajonivritti lakshnas w.s.r. To Post menopausal symptoms.	Duration of therapy everyday 2 months.

Secondary Outcome

Outcome	TimePoints
1. To apply the Menopausal rating scale for assessment of symptoms before and after the treatment. 2. To achieve relief in post menopausal symptoms as per Menopausal Rating scale. 3.To study the Rajonivritti lakshnas and Post Menopausal symptoms. 4.To improve Quality of life. 5.To achieve the Outcome in a period of 150 days.	Duration of Treatment 2 months and after treatment 3 months

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
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)

30/03/2025

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="1"
Months="6"
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 - Individual participant data that underlie the results reported in this article, after de-identiﬁcation (text, tables, ﬁgures, and appendices).

What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Who will be able to view these files?
Response - Anyone

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 [arsalunkhe98@gmail.com].

For how long will this data be available start date provided 18-03-2025 and end date provided 18-03-2030?
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

This is Randomised Controlled Clinical Study to evaluate the Efficacy of Ghambhariphal churna 3 gm in three divided doses thrice a day with Godugdha after food orally for 2 months in Rajonivritti Lakshanas .

Observation will be made upon symptoms of Rajonivritti.

Study will be carried out in OPD of Streerog and Prasutitantra department of Yashwant Charitable Hospital Kodoli.

Primary Outcome will be Efficacy of Ghambhari Phal Churna 3 gm in three divided doses with Godugdha after food in Rajonivritti Lakshanas w.s.r. To Post Menopausal Syndrome. Secondary Outcome will be to achieve the relief in the Post menopausal Symptoms as per Menopausal Rating Scale.