Comparative Effectiveness of Trinpanchmula Ghanvati with Shveta Parpati in the Management of Pittaja Mutrakriccha (UTI) - Study Protocol for an Open Labelled Randomized Controlled Trial

Abstract

Background- Ayurvedic literature delineates a comprehensive approach for the management of PittajaMutrakriccha, encompassing the administration of herbo-mineral formulations, adoption of therapeutic yogic interventions, and implementation of appropriate lifestyle modifications. The purpose of this study is to compare the efficacy of TrinpanchmulaGhanvati with Shveta Parpati in the treatment of PittajaMutrakriccha patients. Although plenty of formulations are there, but there is no research work done to proof the efficacy of TrinpanchmulaGhanvati in the management of PittajaMutrakriccha. Methodsanddesign- In a prospective, open labelled, randomized controlled trial, 60 patients, between 18 and 50 years, diagnosed with Pittaja Mutrakriccha, presenting with cardinal features of PittajaMutrakriccha as described in Ayurvedic texts, two groups will be randomly assigned. In Group one, the patients will receive TrinpanchmulaGhanvati and in Group two, patients will receive Shveta Parpati. Guidelines regarding Pathya-apathya will be given to both the groups. The course of treatment will last for 14 days for both groups. Outcomes will be evaluated on 7th, 14th (During treatment) & 21st& 28th (post-treatment). Result: The primary outcome will be assessed by checking the grading of the cardinal symptoms of PittajaMutrakriccha mentioned in Ayurvedic texts. Secondary outcome will check for improvement in laboratory investigations and quality of life of the patient. Conclusion: This trial is first to compares the effectiveness of TrinpanchmulaGhanvati with Shveta Parpati in the patients of PittajaMutrakriccha. TrinpanchmulaGhanvati is envisioned to improve the symptoms of PittajaMutrakriccha, thus proving to be effective in management of patients of PittajaMutrakriccha

Introduction

Background

• In Ayurveda, body function relies on the balance of Dosha, Dhatu, and Mala.

• Mutrakriccha refers to painful or difficult urination, with Pittaja Mutrakriccha being the most common type, resembling modern Urinary Tract Infections (UTI).

• Symptoms include burning micturition, straining, urgency, yellow-colored or blood-tinged urine.

• Modern medicine offers UTI treatment, but recurrence is common. Ayurveda claims to reduce recurrence with holistic management.

Study Overview

• Design: Prospective, randomized, open-label, parallel-group, double-arm clinical trial.

• Registration: CTRI/2024/07/070152

• Setting: Institutional Ethics Committee-approved Ayurvedic research study.

• Participants: Adults aged 18–50 years diagnosed with Pittaja Mutrakriccha or presenting with corresponding urinary abnormalities.

• Exclusion: Patients with chronic illnesses (e.g., diabetes, kidney stones, renal failure), infections (STDs, sepsis), or pregnant/lactating women.

Intervention Groups

• Group A: Receives Trinpanchmula Ghanvati – a polyherbal formulation (500 mg, thrice daily for 14 days).

• Group B: Receives Shveta Parpati – a mineral-based formulation (500 mg, twice daily for 14 days).

Key Ingredients

• Trinpanchmula Ghanvati: Includes roots of five grasses (e.g., Desmostachya bipinnata, Saccharum officinarum).

• Shveta Parpati: Composed of potassium nitrate, alum, and ammonium chloride.

Methodology

• Randomization: Computer-generated 1:1 allocation.

• Blinding: Open-label; both participants and researchers know the assigned treatment.

• Consent & Screening: Participants provide informed written consent; detailed patient info sheet is provided in Hindi/English.

• Follow-up: Total of 4 visits – 2 during treatment (Days 7 & 14) and 2 post-treatment (Days 21 & 28).

Outcome Measures

Subjective Assessment (Scored 0–3)

1. Urine color (Peeta Mutrata)

2. Frequency of urination (Muhurmuhur Mutrapravrutti)

3. Burning sensation (Daha)

4. Pain during urination (Ruja)

Objective Parameters

• Urine analysis (RBCs, pus cells, WBCs, culture)

• Blood tests: Hemoglobin (HB), TLC, DLC

• Monitored on Day 0 and Day 14

Withdrawal Criteria

• Patients experiencing major side effects, requiring alternate treatment, or unwilling to continue will be withdrawn.

Goals of the Study

• To evaluate the effectiveness of Ayurvedic treatments for Pittaja Mutrakriccha.

• To measure symptom relief, lab improvements, and potentially reduce recurrence compared to conventional UTI management.

Conclusion

The fundamental components of body are Dosha, Dhatu and Mala. Dosha and Dhatu balance is essential for a healthy body, and regular and adequate Mala excretion is just as vital. Among the trimala, Mutra is responsible for Basti Poorana and Kleda Vahanam. Basti (Urinary Bladder) and Vankshana (Genital area) have been considered as the root/base of MutravahaSrotas and their dysfunction leads to excessive urination or oliguria/dysuria, increased frequency and painful micturition [1].

References

[1] Shastri K, Pandeya G. Charaka Samhita of Agniveha (Hindi). Varanasi: Chaukhambha Sanskrit Sansthan; reprint ed. 2022, Vimana Sthana, Chapter 5, Verse 8, p.593. [2] Upadhyaya Y. Madhav Nidana of Shri Madhavakara (Hindi). Varanasi: Chaukhambha Prakashan; reprint ed. 2016, Part -1, MutrakricchaNidanam Adhyaya 30, Verse1-2, p. 551. [3] Kalita A, Kalita H. A Study on different types of MutrakricchaVyadhi with Special Reference to Urine culture examination. IJAPR. March 2018;6(3):885. [4] Shastri K, Pandeya G. Charaka Samhita of Agniveha (Hindi). Varanasi: Chaukhambha Sanskrit Sansthan; reprint ed. 2022, Chikitsa Sthana, Chapter 26, Verse 34, p. 640. [5] Mireles ALF, Walker JN, Caparon M, Hultgren SJ. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nat Rev Microbiol. May 2015;13(5):269– 284. [6] Shastri KA. Bhaishajya Ratnavali. Varanasi: Chaukhamba Sanskrit Sansthan; 2016, chapter 34, Mutrakriccha chikitsa, verse 20, p. 494. [7] Ayurvedic Formulatory of India, Part 2, First English Edition, Government of India: Ministry of Health and Family Welfare; 2000. Formulations parpati; 12:2 p.195 8. [8] Shastri K, Pandeya G. Charaka Samhita of Agniveha (Hindi). Varanasi: Chaukhambha Sanskrit Sansthan; reprint ed. 2022, Chikitsa Sthana, Chapter 26, Verse 34, p. 640. [9] Gebretensaie Y, Atnafu A, Girma S, Alemu Y, Desta K. Prevalence of Bacterial Urinary Tract Infection, Associated Risk Factors, and Antimicrobial Resistance Pattern in Addis Ababa, Ethiopia: A Cross-Sectional Study. Infection and Drug Resistance. May 2023;16:3041-3050. doi: 10.2147/IDR.S402279. PMID: 37215305; PMCID: PMC10199700. [10] Sharma PV. Dravyaguna Vijnana. Varanasi: Chaukhambha Bharti Academy; 2015, Vol. II, Chapter 8, p.634-636. [11] Chunekar KC. Bhavprakash Nighantu by Shri Bhavmishra. Guduchyadivarga, Varanasi: Chaukhambha Bharti Academy; 2022, p.365-366. [12] Sharma PV, DravyagunaVijnana.Varanasi: Chaukhambha Bharti Academy; 2015, Vol.II, Chapter 8, p.637. [13] Sharma PV, DravyagunaVijnana.Varanasi: Chaukhambha Bharti Academy; 2015, Vol.II, Chapter 8, p.638-639. [14] Trikamji J. SiddhayogaSangraha. Nagpur: Shri Vaidyanatha Ayurveda Bhavana; reprint ed. 2013, AshmariMutrakrichra Adhikara, Chapter 18, p.97. [15] Angadi R. Rasatarangini. Varanasi: ChaukhambaSurbharati Prakashan; reprint ed. 2015, Chapter14, Verse 28,p.224. [16] Balakrishnana G, Vineeth PK, Ramesh NV. Effect of Shweta Parpati in Mutrakrichra: An Article Review. Journal of medical pharmaceuticals and allied sciences, January 2017:588-595.

Copyright

Copyright © 2025 Dr. Bharti Yadav, Dr. Neha Lamba, Dr. Neelam Kumari. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.