CTRI

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CTRI Number

CTRI/2023/06/054081 [Registered on: 19/06/2023] Trial Registered Prospectively

Last Modified On:

17/06/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Preventive

Study Design

Single Arm Study

Public Title of Study

Effect of digestive power with darvyadi lauh in Anaemia

Scientific Title of Study

An assessment of role of Agni in Pandu roga and its upshayatmaka parikshana with Darvyadi Lauha

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	MD Scholar
Affiliation	Government Ayurveda P G College and Hospital Varanasi
Address	Department of Roga Nidana Evum Vikriti Vigyana Government Ayurvedic PG College and Hospital Varanasi Varanasi UTTAR PRADESH 221002 India
Phone	9458388998
Fax
Email	monicarawat.109@gmail.com

Details of Contact Person
Scientific Query

Name	DR AVADHESH KUMAR
Designation	Associate professor and HOD PG department of Roga Nidana Evum Vikriti Vigyana
Affiliation	Government Ayurveda P G College and Hospital Varanasi
Address	Department of Roga Nidana Evum Vikriti Vigyana Government Ayurvedic PG College and Hospital Varanasi Varanasi UTTAR PRADESH 221002 India
Phone	9455262663
Fax
Email	dravadheshsaroj@gmail.com

Details of Contact Person
Public Query

Name	DR MONIKA
Designation	MD Scholar
Affiliation	Government Ayurveda P G College and Hospital Varanasi
Address	Department of Roga Nidana Evum Vikriti Vigyana Government Ayurvedic PG College and Hospital Varanasi Varanasi UTTAR PRADESH 221002 India
Phone	9458388998
Fax
Email	monicarawat.109@gmail.com

Source of Monetary or Material Support

Government Ayurvedic PG college and Hospital Varanasi

Primary Sponsor

Name	Government Ayurvedic PG college and Hospital Varanasi
Address	Department of Roga Nidana Evum Vikriti Vigyana Government Ayurvedic PG college and Hospital Varanasi
Type of Sponsor	Government 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 MONIKA	Government Ayurvedic PG college and Hospital Varanasi	Department of Roga Nidana Evum Vikriti Vigyana Government Ayurvedic PG college and Hospital Varanasi Varanasi UTTAR PRADESH	9458388998 monicarawat.109@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee Government Ayurveda College and Hospital Varanasi Uttar Pradesh	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:D539\|\|Nutritional anemia, unspecified. Ayurveda Condition: PANDUROGAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Darvyadi Lauha, Reference: Chakradutta Pandu Roga chikitsa prakaran (8/29), Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu-sarpi), Additional Information:

Inclusion Criteria

Age From	16.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1. Patients will be selected irrespective of their sex, occupation, religion, caste etc. 2. Patient with signs and symptoms of Pandu Roga (Anaemia). 3. Patient of age group between 16-70 yrs. 4. Blood sample having Hb 6.5 gm% to 11 gm%. 5. Patient having low level of RBC count, PCV, MCV, MCH, MCHC. 6. Marital status â€“ Married and unmarried both.

ExclusionCriteria

Details

1. Patients below 16 years and above 70 years.
2. Blood sample having Hb % less than 6.5 gm%.
3. Any haemorrhagic disorder or hereditary condition like Thalassemia, Sickle cell Anaemia, Leukaemia, Aplastic Anaemia, Anaemia due to bleeding piles, Menorrhagia etc.
4. Patient having any other major complicated disease like Cardiac disease, Leukaemia, Chronic renal disease etc.
5. Patients having any congenital anomaly.
6. Mentally Retarded and psychological ill person.
7. Pregnant woman.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To decrease signs and symptoms of anemia	15 days

Secondary Outcome

Outcome	TimePoints
To cure Anaemia.	30 days

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4

Date of First Enrollment (India)

26/06/2023

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

NIL

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary

This study is an Interventional open and Randomized Controlled Clinical Trial where the review of relevant literature from Ayurveda Classics, modern medical science, journals, previous research, and the internet in great depth for the conceptualization of the role of Agni in the etiopathogenesis of Pandu Roga and probable mode of action of Ayurvedic drug Darvyadi Lauha in Pandu roga. Patients will be randomly selected from O.P.D/I.P.D of the Department of Roga Nidana Evum Vikriti Vigyana, Government PG College and Hospital, Varanasi. 60 Patients will be studied.