CTRI

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CTRI Number

CTRI/2025/03/082052 [Registered on: 10/03/2025] Trial Registered Prospectively

Last Modified On:

08/03/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Manjishthadi Agad in Pandu.

Scientific Title of Study

Randomised contolled clinical trials to evaluate the efficacy of Manjishthadi Agad in management of Garavishajanya Pandu.

Trial Acronym

nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Nanda Manohar Dhabadkar
Designation	PG Scholar
Affiliation	Government Ayurvedic College Tulajapur Naka Dharashiv
Address	Agadatantra OPD 12 Ground Floor Government Ayurvedic College And Hospital Tuljapur Naka Dharasiv Agadatantra Department Second Floor Government Ayurvedic College Dharashiv Osmanabad MAHARASHTRA 413501 India
Phone	9172774597
Fax
Email	dhabadkarnanda2019@gmail.com

Details of Contact Person
Scientific Query

Name	DR N S Gangasagre
Designation	HOD OF Agadatantra Department
Affiliation	Government Ayurvedic College Tulajapur Naka Dharashiv
Address	Agadatantra OPD 12 Ground Floor Government Ayurvedic College And Hospital Tuljapur Naka Dharasiv Osmanabad MAHARASHTRA 413501 India
Phone	09422165970
Fax
Email	gacosbd@gmail.com

Details of Contact Person
Public Query

Name	DR N S Gangasagre
Designation	HOD OF Agadatantra Department
Affiliation	Government Ayurvedic College Tulajapur Naka Dharashiv
Address	Agadatantra OPD 12 Ground Floor Government Ayurvedic College And Hospital Tuljapur Naka Dharasiv Osmanabad MAHARASHTRA 413501 India
Phone	09422165970
Fax
Email	gacosbd@gmail.com

Source of Monetary or Material Support

Government Ayurvedic college Dharashiv 413501

Primary Sponsor

Name	Government Ayurvedic College And Hospital
Address	OPD no 13 first floor Government Ayurvedic College And Hospital Tuljapur Naka Dharashiv 413501 Maharashtra India
Type of Sponsor	Other [ Government Ayurvedic College And Hospital Dharashiv]

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 Nanda Manohar Dhabadkar	Government Ayurvedic College and Hospital Dharashiv	OPD no 12 Agadatantra department Division B Ground Floor Government Ayurvedic College And Hospital Tuljapur Naka Dharasiv 413501 India Osmanabad MAHARASHTRA	09422165970 nandadhabadkar2019@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Commit Government Ayurvedic College Dharashiv	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:T629\|\|Toxic effect of unspecified noxious substance eaten as food. Ayurveda Condition: PANDUROGAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Manjishthadi agad, Reference: Bharat Bhaishajya Ratnakara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -

Inclusion Criteria

Age From	15.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Patients selected by irrespective of Cast Economic status religion Who gives informed written concent

ExclusionCriteria

Details

Patients who dont give informed written consent
lactating mother And Pregnant Woman
Bleeding disorders
Patients participating in any other clinical trials
Hb percentage below 7%
severe systemic diseases like Ascites CCF ARF CRF AIDS TB Leprocy Any Malignancy Gastric ulcer Autoimmune diseases
Patients who is on other medications
surgical disorders like Appendix hernia

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To evaluate the efficacy of Manjishthadi Agad in management of Garavishajanya Pandu.	On 0th day, 15th day, 30th day, 45th day, 60th day.

Secondary Outcome

Outcome	TimePoints
Standardization and Analytical study of Manjishthadi Agad. To study the Panduroga in detail.	On 0th day, 15th day, 30th day, 45th day, 60th day.

Target Sample Size

Total Sample Size="194"
Sample Size from India="194"
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)

22/03/2025

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 Applicable

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 - NO

Brief Summary

After clearance of institutional ethics of Government Ayurvedic College Dharashiv, screening of population will be done from patient in IPD and OPD of our institute. in clinical study of 194 patients of Garavishajanya Pandu will be include. if patients fulfill the criteria of inclusion, subject will also give freedom to ask their questions all questions would answer. If he/she agrees for participation in study and found fit to include the patient will include in study.

The treatment will be given to patient as follows:

Group A (Trial Group) - Manjishthadi Agad -5gm, BID (for 2 months) + Tab. Orofer XT 1OD (for 2 months)

Group B (Control Group) - Tab. Orofer XT 1OD (for 2 months)

In study Assessment of Gading scale of symptoms and CBC will be taken and ESR will be assessed as per need on 0^thday, 15^th Day, 30^th Day, 45^th Day and final assessment of patient will be done on 60^th day.

Medium of Dissertation: The study will be written in English and Sanskrit words will be used wherever necessary.

Study Design: Randomized Control Clinical Trial.

Duration of Treatment: 2 Months

Ethical Clearance: Clearance from Institutional Ethics Committee will be taken.

Study Centre: OPD, IPD of Mother institute, Civil Hospital and periphery.

Duration of study: Study will be carried out for 18 months.

Study Population:

1. All the patients of Garavishajanya Pandu attending OPD, IPD and periphery of

our institute will be considered in this study.

2. Patients in between 15 to 60 years of age.

3. Patients will be diagnosed on the basis of symptoms and laboratory investigations.

4.Pandu is Garavishajanya or not will be assessed on the basis of questionnaire. (Questionnaire which contains questions about Garvisha’s Hetu)

Sample Size: Sample size calculated by Daniel’s formula.

Prevalence of Anemia in Osmanabad district is 49.1%.

Daniel’s formula-

Sample size for (n)= (z) p(1-p)/e²

Where n = Sample Size

z= Level of Signification (1.96)

p = Prevalence Rate (49%)

e Standard Error (10%)

n = (1.96) x 0.49(1-0.49) ÷ (0.1) ²

n=3.84x0.49× 0.51+0.01

n=97

Assessment will be done on the basis of following criteria’s:

A) Subjective Criteria: 1) Gradation of Panduta.

2) Gradation of Daurbalya

3) Gradation of Shwas

4) Gradation of Aruchi

5) Gradation of Pindikodwestan

6) Gradation of Akshikut-shoth

B) Objective Criteria: CBC- Hb

MCV

MCH

MCHC

CBC will be carried out before treatment and at the end of treatment. To see the Microcytosis, hypochromic cells and Hb%.

C) Overall Assessment Criteria: - Overall assessment will be done on the basis of Maked Improvement, Moderate Improvement, Mild Improvement, No Improvement.

Finally, Observation, Discussion, Conclusion will be done.