Treatment of kidney stone with Unani medicine Jawarish Zarooni Sada

Phase 3

Not yet recruiting

• Conditions: Calculus of kidney,

• Registration Number: CTRI/2022/10/046645
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

This study is designed as a single centric open trial in patients with **HasÄh al-Kulya (Nephrolithiasis)****.**After screening, patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically at every two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 8 weeks. Laboratory parameters for safety assessment will be conducted at baseline, 4 weeks and on completion of the protocol therapy.

**Composition of Jawarish Zarooni Sada**

| | | | |

| --- | --- | --- | --- |

|**S. No.**

**Name of the drug**

**Scientific name**

**Quantity**

|1.

Tukhm-e-Gajar

Daucus carota Linn.

30gms

|2.

Tukhm-e-Karafs

Apium graveolens L. seeds

30gms

|3.

Tukhm-e-Ispat

Trifolium alexandrinum

30gms

|4.

Nankhwah

Trachyspermum ammi L.

30gms

|5.

Badiyan

Foeniculum vulgare M.

30gms

|6.

Maghz-e-Tukhm-e-

Kharbuz

Cucumis melo L.

30gms

|7.

Maghz-e-Tukhm-Khiyarain

Cucumis sativus L.

30gms

|8.

Post-e-Beekh-e-Karafs

Apium graveolens L. root

30gms

|9.

Qaranful

Syzygium aromaticum L.

30gms

|10.

FilfilSiyah

Piper nigrum L.

30gms

|11.

Aaqarqarha

Anacyclus pyrethrum DC.

10gms

|12.

Darchini

Cinnamomum zeylanicum

10gms

|13.

Zafran

Crocus sativus L.

10gms

|14.

Mastagi

Pistacia lentiscus L.

10gms

|15.

Ood Hindi

Aquilaria agallocha R.

10gms

|16.

Bisbasa

Myristica fragrans H.; fruit rind

10gms

|17.

Asal or Qand Safaid

Honey or Sugar

1kg

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-10-18
• Study Start: 2022-10-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Patients of either gender in the age group 18-65 years.
• Patients with HasÄh al-Kulya (Nephrolithiasis) as diagnosed by USG (KUB) with calculi measuring up to 5 mm (single or multiple) with or without any of the following symptoms: Pain or heaviness in flank region Pain or heaviness in groin/loin region Urinary urgency Nausea and vomiting.

Exclusion Criteria

• Size of calculi above 5 mm 2.
• Patients with Renal colic and Hydronephrosis 3.
• Patients having impacted stones 4.
• Previous history of stone surgery 5.
• Patients with signs of renal failure 6.
• Pregnant and lactating women 7.
• Known cases of Hepatic, Renal or Cardiac ailments 8.
• Patients having systemic disease requiring long term treatment like Diabetes mellitus, Hypertension etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of the drug will be assessed on the basis of following parameters:	At baseline, 2, 4, 6 and 8 weeks
2. Radiological Parameters- Ultrasound KUB will be taken as criteria for detection of reduction in stone size or expulsion of stone.	At baseline, 2, 4, 6 and 8 weeks
3. Frequency of Rescue medication used during the protocol duration.	At baseline, 2, 4, 6 and 8 weeks
1. Clinical Parameters i.e. Reduction in signs and symptoms.	At baseline, 2, 4, 6 and 8 weeks
4. Classical Examination of Urine (Nazri Muana-e-Bawl)	At baseline, 2, 4, 6 and 8 weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	At baseline, 4 and 8 weeks

Trial Locations

Locations (1)

Central Research Institute of Unani Medicine (CRIUM), Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

Central Research Institute of Unani Medicine (CRIUM), Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Shamsul Arfeen

Principal investigator

9450389873

sarfeen0110@yahoo.co.in