CTRI

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CTRI Number

CTRI/2024/10/075651 [Registered on: 22/10/2024] Trial Registered Prospectively

Last Modified On:

03/10/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Non-randomized, Active Controlled Trial

Public Title of Study

A CLINICAL STUDY TO COMPARE THE EFFECT OF BAVITHA TRIPHALA (PROCESSED TRIPHALA)AND NAVA GULUGLULU IN DYSLIPIDEMIA (MEDOROGA)

Scientific Title of Study

Comparative Clinical Evaluation Of Processed Triphala in the Management of Dyslipidemia

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 ARYA PRABHU
Designation	ASSOCIATE PROFESSOR
Affiliation	MANNAM AYURVEDA COOPERATIVE MEDICAL COLLEGE
Address	DEPARTMENT OF DRAVYAGUNA VIGNANA FIRST FLOOR ROOM NO 309 MANNAM AYUVEDA CO OPERATIVE MEDICAL COLLEGE PANDALAM M S M PO PANDALAM PIN 689501 Pathanamthitta KERALA 689501 India Pathanamthitta KERALA 689501 India
Phone	9497497647
Fax
Email	draryaprabhu@gmail.com

Details of Contact Person
Scientific Query

Name	DR AJITH KUMAR R
Designation	PROFESSOR
Affiliation	Shri JJT University
Address	Department of Ayurveda First floor Shri JJT University Vidyanagari, Jhunjhunu Churu Road, Chudela, District - Jhunjhunu Rajasthan - 333010 Jhunjhunun RAJASTHAN 333010 India
Phone	8848384191
Fax
Email	ayudrajith@gmail.com

Details of Contact Person
Public Query

Name	DR ARYA PRABHU
Designation	ASSOCIATE PROFESSOR
Affiliation	MANNAM AYURVEDA COOPERATIVE MEDICAL COLLEGE
Address	DEPARTMENT OF DRAVYAGUNA VIGNANA FIRST FLOOR ROOM NO 309 MANNAM AYUVEDA CO OPERATIVE MEDICAL COLLEGE PANDALAM M S M PO PANDALAM PIN 689501 Pathanamthitta KERALA 689501 India Pathanamthitta KERALA 689501 India
Phone	9497497647
Fax
Email	draryaprabhu@gmail.com

Source of Monetary or Material Support

MANNAM AYURVEDA CO OPERATIVE MEDICAL COLLEGE MSM PO PANDALAM PIN 689501 DISTRICT PATHANAMTHITTA STATE KERALA

Primary Sponsor

Name	MANNAM AYURVEDA CO OPERATIVE MEDICAL COLLEGE MSM PO PANDALAM PIN 689501
Address	MSM PO PANDALAM PATHANAMTHITTA DISTRICT PIN 689501
Type of Sponsor	Other [PRIVATE AYURVEDA MEDICAL COLLEGE]

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 ARYA PRABHU	MANNAM AYURVEDA CO OPERATIVE MEDICAL COLLEGE ,PANDALAM	DEPARTMENT OF DRAVYAGUNA VIGNANA FIRST FLOOR ROOM NO 309 MANNAM AYUVEDA COOPERATIVE MEDICAL COLLEGE PANDALAM M S M PO PANDALAM PIN 689501 Pathanamthitta KERALA 689501 India Pathanamthitta KERALA 689501 India Pathanamthitta KERALA	9497497647 draryaprabhu@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICAL COMMITTEE MANNAM AYURVEDA COOPERATIVE MEDICAL COLLEGE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:I998\|\|Other disorder of circulatory system. Ayurveda Condition: MEDOROGAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: BAVITHA TRIPHALA CHOORNAM, Reference: CHIKITSAMANJARI AYURVEDAM STHULACHIKITSA SLOKA NUMBER 4, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: HONEY), Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: NAVAGULGULU, Reference: ASHTAMGAHRUDAYAM, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: LUKE WARM WATER), Additional Information: -

Inclusion Criteria

Age From	30.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patients of both sexes having any one or all of the following altered lipid levels will be selected. (ATP III Guidelines, NCEP) Total cholesterol above 200mg/ di LDL cholesterol above 130mg/di HDL cholesterol below 40 mg/di Triglycerides above 150mg/di Age group- 30 - 70 years Patients are informed of the given written consent.

ExclusionCriteria

Details

Patients in the age group below 30 years and above 70 years.
Patients having serious Cardiac disorders like MI and cardiac failure.
Pregnant and lactating women.
Severe hepatic disorders.
The patient has a history of untreated thyroid disorders.
Uncontrolled Diabetes mellitus
Known case of any type of Malignancy, Renal insufficiency.
Patients who are not willing to participate in the study.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome

TimePoints

Evaluation of the efficacy of this intervention on serum Lipid levels, Body weight, Body Mass Index (BMI), and Fasting Blood Glucose, will be evaluated before treatment and on the 15th, 30th day and 45th day during the treatment. Changes in subjective criteria like Palpitation, exertional dyspnea, fatigue, corneal arcus, and xanthelasma will also be interrogated and recorded before treatment and after completion of the intervention. Conclusions were drawn. using appropriate statistical techniques.

15th, 30th day and 45thday -DURING THE TREATMENT

Secondary Outcome

Outcome	TimePoints
ASSES THE COMPARATIVE EFFICACY BETWEEN PROCESSED TRIPHALA AND NAVAGULGULU IN DYSLIPIDEMIA	FOLLOW UP-3 MONTHS

Target Sample Size

Total Sample Size="200"
Sample Size from India="200"
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

N/A

Date of First Enrollment (India)

28/10/2024

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="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Yet Recruiting

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
Modification(s)

According to Ayurveda Dyslipidemia can be correlated under Medoroga or Medodushti. The aetiology of Dyslipidemia, to a great extent, is like the Nidana of Medodushti. The increase in Medodhatu due to Medodhatwagni mandya and vitiated Medodhatu led to Srotoavarrodha and Vata Prakopa, which impairs the Dhatuparinam process a condition that arises due to medovridhi which in turn restricts the nourishment of other dhatus. This study aims the effect of processed Bavitha Triphala in the management of Dyslipidemia. The study will be conducted as a comparative clinical trial. The subjects will be selected based on the detailed clinical proforma and according to inclusion criteria from the Out Patient Department of Mannam Ayurveda Co-operative Medical College Pandalam, Kerala

Particulars	Group A	Group B
Sample size	100	100
Drug	Processed Triphala	Navagulggulu
Form	Powder	Tablet
Dose	10gm (5gm twice daily)	2 Nos (1 tab twice a day)
Anupana	Honey	Luke warm water
Duration	45 Days	45 Days

Evaluation of the efficacy of this intervention on serum Lipid levels, Body weight, Body Mass Index (BMI), and Fasting Blood Glucose, will be evaluated before treatment and on the 15^th, 30^th day and 45^thday during the treatment. Changes in subjective criteria like Palpitation, exertional dyspnea, fatigue, corneal arcus, and xanthelasma will also be interrogated and recorded before treatment and after completion of the intervention. Conclusions were drawn. using appropriate statistical techniques.