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Clinical Trials/CTRI/2022/11/047625
CTRI/2022/11/047625Not yet recruitingPhase 2/3

Comparative controlled clinical study to evaluate efficacy of Indrashani Choorna and ferrous sulphate in Pandu Vyadhi with special reference to iron deficiency anemia.

Dr Ritesh D Damle2 sites in 1 country162 target enrollmentStarted: January 12, 2022Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
162
Locations
2
Primary Endpoint
To observe the changes in signs and symptoms of Pandu with use of Indrashani

Study Overview

Brief Summary

For the present study, Indrashani Choorna mentioned in Choorna chapter of Sahasrayoga, has been selected, which comprises of Tila, Pippali, Badara, Madhu, Makshika, Ayas, Shunthi and Sita. The research hypothesis is that, Indrashani choorna is helpful in the management of Panduroga with special reference to Iron deficiency Anaemia.

Expected outcome:• Significant improvement in subjective and objective parameters is expected in this comparative clinical study.• Jujube (Badara) was reported to contain numerous minerals. About 0.48 mg iron and 69 mg vitamin C per 100 g of fresh fruit were reported. Being intrinsically rich in potassium, phosphorus, manganese, iron, zinc these minerals help in maintaining cardiac health. Jujube is a great way to pump iron reserves, improve hemoglobin count and regulate thus, the daily intake of jujube could increase our dietary iron and vitamin, as to prevent anemia due to deficiency of iron or vitamin C.Hence, Indrashani choorna is expected to increase Hemoglobin level, significantly.• Since, Indrashani choorna is combination of indigenous compound drug, it is expected to get well tolerated and clinically safe and better alternative for ferrous sulphate which is having much adverse effect in management of IDA.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • “Pandu Vyadhi†will be diagnosed on the basis of symptoms of Pandu Vyadhi. 2) Age: 18-60 Yrs. Irrespective of gender, religion, Socio.
  • economic status, marital status. 3) Hb % more than 7 gm% & less than normal i.e. Male -< 13g / dl. And female -<12g/dl. 4) MCV less than normal. [
  • 100 fl]. 5) PBS – Microcytic hypochromic (morphology) 6)Sr. Iron: below 70 mcg.

Exclusion Criteria

  • Known case of Endocrine disorders like Diabetes mellitus, hypothyroidism, Cushing syndrome, etc.
  • Pregnant and lactating lady.
  • Patient having Tuberculosis, known case of HIV, leprosy, any type of cancer.
  • Patient showing signs and symptoms of internal bleeding Haemorrhoids, menorrhagia etc.

Outcomes

Primary Outcomes

To observe the changes in signs and symptoms of Pandu with use of Indrashani

Time Frame: At Day 0, Day 15th, Day 30th, Day 45

Choorna while comparing with ferrous sulphate.

Time Frame: At Day 0, Day 15th, Day 30th, Day 45

Secondary Outcomes

  • To observe the changes in biochemical parameters in patients of Pandu Vyadhi with(the use of Indrasani Choorna while comparing with ferrous sulphate. (Hb, MCV,)

Investigators

Sponsor
Dr Ritesh D Damle
Sponsor Class
Other [self]

Study Sites (2)

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