Manjishthadi Agad in Pandu.

Phase 2/3

Not yet recruiting

• Conditions: Toxic effect of unspecified noxious substance eaten as food. Ayurveda Condition: PANDUROGAH,

• Registration Number: CTRI/2025/03/082052
• Lead Sponsor: Government Ayurvedic College And Hospital

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 0thday, 15th Day, 30th Day, 45th Day and final assessment of patient will be done on 60th 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-22
• Last Update Posted: 2025-08-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

Patients selected by irrespective of Cast Economic status religion Who gives informed written concent.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Standardization and Analytical study of Manjishthadi Agad.	To study the Panduroga in detail.

Trial Locations

Locations (1)

Government Ayurvedic College and Hospital Dharashiv; 🇮🇳 Osmanabad, MAHARASHTRA, India

Government Ayurvedic College and Hospital Dharashiv

🇮🇳Osmanabad, MAHARASHTRA, India

Dr Nanda Manohar Dhabadkar

Principal investigator

09422165970

nandadhabadkar2019@gmail.com