CTRI

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CTRI Number

CTRI/2015/02/005547 [Registered on: 16/02/2015] Trial Registered Retrospectively

Last Modified On:

02/12/2016

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A study to investigate the effect of Nagapheni (Optunia elatior Mill.) in the treatment of anemia.

Scientific Title of Study

A Pharmacological and Pharmacotherapeutical evaluation of fruit of Nagapheni (Opuntia elatior Mill.) on Pandu

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Prajapati Shashikant
Designation	PhD Scholar
Affiliation	I P G T and R A GAU Jamnagar
Address	Room no 88 P G Boys Hostel I P G T and R A Gujarat Ayurveda University Jamnagar 361 008 Room no 88 P G Boys Hostel I P G T and R A Gujarat Ayurveda University Jamnagar 361 008 Jamnagar GUJARAT 361 008 India
Phone	9428563834
Fax
Email	dr.shashi_ayu@yahoo.com

Details of Contact Person
Scientific Query

Name	Prof R N Acharya
Designation	Professor
Affiliation	I P G T and R A GAU Jamnagar
Address	Room no 323 Institute building I P G T and R A Gujarat Ayurveda University Jamnagar 361 008 Jamnagar GUJARAT 361 008 India
Phone	9924585855
Fax
Email	drrnacharya@gmail.com

Details of Contact Person
Public Query

Name	Prajapati Shashikant
Designation	PhD Scholar
Affiliation	I P G T and R A GAU Jamnagar
Address	Room no 88 P G Boys Hostel I P G T and R A Gujarat Ayurveda University Jamnagar 361 008 Room no 88 P G Boys Hostel I P G T and R A Gujarat Ayurveda University Jamnagar 361 008 GUJARAT 361 008 India
Phone	9428563834
Fax
Email	dr.shashi_ayu@yahoo.com

Source of Monetary or Material Support

I P G T AND R A Gujarat Ayurveda University Jamnagar

Primary Sponsor

Name	Institute for post gradute teaching and research in Ayurevda gujarat ayurveda university jamnagar
Address	IPGT AND RA GUJARAT AYURVEDA UNIVERSITY JAMNAGAR
Type of Sponsor	Research institution

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
Shashikant Prajapati	IPGT AND RA JAMNAGAR	Room no 17 Department of Dravyaguna IPGT and RA Gujarat Ayurveda University Jamnagar Jamnagar GUJARAT	9428563834 dr.shashi_ayu@yahoo.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
PGT/7/-A/Ethics/2014-15/2652	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Patients selected on the basis of the classical symptoms of Pandu(anaemia) and Level of Hb is low to normal value,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Opuntia elatior Mill.	0ml swarasa/day with luke warm water duration 2 months follw up 1 month

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Patients between age of 18-60 yrs Irrespective of sex Diagnosed Pandu as per with classical symptomsHb% below 12gm (F) and below 13gm (M) or reduced RBC count

ExclusionCriteria

Details

Age less than 18 years and more than 60 years
Pregnancy and lactation
Severe Renal Hepatic Cardiac disease Cancer
Any continuing blood loss e g Hematemesis Melaena Bleeding piles etc

Method of Generating Random Sequence

Other

Method of Concealment

Other

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
relief in the of symptoms on Pandu(anaemia)like Panduta (Pallor, Panduta (Pallor)etc.	Hemoglobin will be estimated after 2 month of trial drug Opuntia elatior Mill.

Secondary Outcome

Outcome	TimePoints
relief in Shrama (Fatigue), Shwasa (Exertional Dyspnoea) etc.	upto present study

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial

N/A

Date of First Enrollment (India)

06/02/2015

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

no publication

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary
Modification(s)

Present open labelled, randomised clinical trial was planned to evaluate the efficacy of the Nagaphani fruit Swarasa (Opuntia elatior Mill.) in the management of Pandu (anaemia). Well known drug, Punarnava Mandura was taken as comparator drug as it is experimentally as well as clinically proved effective drug for Pandu. Total 105 patients were registered and randomly divided into two groups. In group A Nagaphani Swarasa was administrated at a dose of 20ml twice a day with luke warm water before meal while group B received Punarnava Mandura at a dose of 500mg two tablet twice a day with Takra before meal for the duration of 2 months with 1 month follow up. At the end of the trial both drugs were found effective in the management of Pandu by significantly significant (p<0.001) relieving in all the cardinal symptoms of Pandu. Both groups produced statistically significant increase in Hb%, TRBC and Serum Iron. In TIBC, group A shows statistically significant result (p>0.05) while group B produced statistically insignificant result (p>0.05). But the difference in between is insignificant. No adverse reactions were reported during the clinical trial indicating safety of Nagaphani Swarasa. Thus, alternative hypothesis is accepted stating that Nagaphani (Opuntia elatior Mill.) fruit can be used in the treatment of Pandu.