A Randomised Open Labelled comparative clinical study to evaluate effect of Hamsapadi(adiantum lunulatum burm) and Gokshura(tribulus terrestris linn) in pittaja mutrakruchra with special referance to UTI

NEED FOR THE STUDY

Ayurveda has given prime importance to Mutravaha srotas (Urinary System) and srotogata vikaras (Urinary disorders). Being a system responsible for homeostasis of fluids in the body. It also detoxifies the body by eliminating certain waste products through urine.

Hamsapadi (Adiantum lunulatum Burm) belonging to family Adiantaceae. This walking fern is cheap and easily available in all over India. It is grown in humus rich, moist, well drained sites.

Charakacharya has mentioned the drug Hamsapadi in Kanthya dashemani.(1) Acharya Sushruta mentioned Hamsapadi in Vidarigandhadi gana.(2) Acharya Vagbhata mentioned Hamsapadi in Vidaryadi gana.(3) The reference of Hamsapadi can be traced from various nighantus like Dhanwantari, Shodhala, Madanpal, Kaiyadev, Bhavprakasha and Raj nighantu etc. .

Gokshura (Tribulus terrestris Linn)(4) is widely used and proven drug in Mutrakruchra by the properties like bastishodhana, mutrala etc. It also acts as Antibacterial in UTI pathogens

Pittaja Mutrakruchra resembles with Urinary tract infection by symptoms of modern medicine. The lakshanas of Pittaja Mutrakruchra are peeta mutrata, sadaha mutrata, kruchra mutrata, sarakta mutrata, muhur muhur mutrapravrutti.(5) Lower Urinary tract infection commonly cause dysuria with burning micturition, increased frequency and urgency.(6) The disease Pittaja Mutrakruchra is well acknowledged in classical texts of ayurveda, with different treatment modalities which can be concurrent to Urinary tract infection on theoretical and clinical symptomatology of diseases.

According to modern medicine, UTI are the second most common type of infection in the body accounting for about 7 million visits to health care providers each year. 50% women will be treated for at least once UTI during their life time.(7) UTI commonly encounters with E.coli accounts for about 90% of community acquired.(8) In modern treatment Antibiotics are given for UTI. But antimicrobial resistance is very high to the commonly prescribed antibiotics in various Indian studies and ICMR AMR network data.(9) Various studies shown that almost all diuretics have many adverse effects..(10)

In Pittaja mutrakruchra in order to pacify the ushna tikshna guna of Pitta which is responsible for sadaha, sarakta, sapeeta mutrapravrutti, There is need of the drugs which are mutrala, dahashamaka, shoolahara properties by virtue of Kashay and madhur ras, sheeta virya, madhur vipaka. We find the same properties in Hamsapadi(11) and Rasayana,(12) Raktaprasadana, Pittashamaka, Dahashamaka , Vishaghna(13) properties attributed to Hamsapadi.

At this scenario of present life, there is more demand for safe, cost effective herbal medicine, hence, Hamsapadi drug which is sparsely explored drug is taken for the study to compare its effectiveness over proven drug Gokshura.

So keeping all facts in mind above study entitled - “A RANDOMISED OPEN LABELLED COMPARATIVE CLINICAL STUDY TO EVALUATE EFFECT OF HAMSAPADI (Adiantum lunulatum Burm) AND GOKSHURA (Tribulus terrestris Linn) IN PITTAJA MUTRAKRUCHRA WITH SPECIAL REFERANCE TO UTI”

is undertaken.

OBJECTIVES OF THE STUDY:

To study the preliminary pharmacognostic and phytochemical analysis of the Hamsapadi churna and Gokshura churna.

To assess the efficacy of hamsapadi churna in UTI.

To assess the efficacy of Gokshura churna in UTI.

To compare the efficacy of Hamsapadi churna and Gokshura churna in the management of UTI.

STUDY DESIGN

STUDY TYPE:

Randomised open labelled comparative clinical study.

Estimated enrolment : - 40

Intervention Model : - Comparative two arm study.

Allocation : - Randomised

Masking : - Open

Primary Purpose : - Treatment

DIAGNOSTIC CRITERIA:

Classical signs and symptoms of Pittaja Mutrakruchra.

CBC.

RBS.

ESR.

Urine routine microscopic.

INCLUSION CRITERIA:

Subject having Saruja mutrata (Pain during micturition), Sadaha mutrata (Burning micturition), Muhur muhur mutrapravrutti, Peeta mutrata, Sarakta mutrata (Hematuria).

Subject having age between 18 to 70 years.

Diagnosed case of UTI.

EXCLUSION CRITERIA:

Subject present with Pyelonephritis, Prostatitis.

Subject present with chronic severe disorders like; Chronic renal failure, Urinary incontinence , Sexually transmitted diseases.

UTI due to Bladder cancer, Genitourinary TB.

Subject having body temp above 101°F.

Who doesn’t provide informed consent

WITHDRAWAL CRITERIA:

Patient can get withdraw from the trial anytime with following reasons or as the case may be;

Health and safety issues

Personal reasons

Noncompliance

Lost to follow up

Randomization error

INTERVENTION:

TOTAL – 40 PATIENTS

GROUP

n =

(No.of patient)

DRUG

DOSE

ANUPANA

DURATION

A

20

Internal administration of Hamsapadi churna

6gm powder BD before food

Warm water

15 Days

GROUP

n=(No.of patient)

DRUG

DOSE

ANUPANA

DURATION

B

20

Internal administration of Gokshura churna

6gm powder BD before food

Warm water

15 Days

METHOD OF PREPARATION:

The fresh samples of Hamsapadi panchanga and Gokshura root will be collected from its natural habitat. It will be dried under shade for sufficient time duration. Then it will be crushed to make coarse powder. Then fine powder will be made using pulveriser. That fine powders of both churna will be collected and stored in appropriate container separately.

DURATION OF STUDY:

15 days.

ASSESSMENT CRITERIA:

Urine routine microscopic test will be considered for the assessment of the treatment. Assessment will be done on 0th day and on 15th day.

The parameters are urine pus cells , epithelial cells , Albumin in urine.

Colour and frequency of urine will note on 0th day and on 15th day.

They will be graded and scores will be given accordingly.

SUBJECTIVE PARAMETERS:

Saruja Mutrapravrutti(Pain during micturition)

SL.NO

SEVERITY

GRADES

1

Absent -

Grade 0

2

Mild (occasional mild pain)-

Grade 1

3

Moderate (often moderate pain) -

Grade 2

4

Severe (severe pain, not tolerable)-

Grade 3

Sadah Mutrapravrutti(Burning micturition)

SL.NO

SEVERITY

GRADES

1

Absent

Grade 0

2

Mild (occasional mild burning)

Grade 1

3

Moderate (Moderate burning with every voiding)

Grade 2

4

Severe (severe burning with every voiding, not tolerable)

Grade 3

Fever and chills(Jwara , sheetapurvaka)

SL.NO

SEVERITY

GRADES

1

Absent

Grade 0

2

Present

Grade 1

Frequency of urination

SL.NO

SEVERITY

GRADES

1

Less than 5 times per day

Grade 0

2

5-8 times per day

Grade 1

3

8-12 times per day

Grade 2

4

More than 12 times per day

Grade 3

Peeta Mutrata(Yellow Colour urine)

SL.NO

SEVERITY

GRADES

1

Pale yellow colour (Normal colour of urine)

Grade 0

2

Mild yellow colour-

Grade 1

3

Yellow Colour-

Grade 2

4

Deep yellow colour-

Grade 3

OBJECTIVE PARAMETERS:

Urine Albumin

SL.NO

SEVERITY

GRADES

1

No albumin-

Grade 0

2

Trace-

Grade 1

3

Present (+)

Grade 2

4

Present (++)

Grade 3

Urinary Epithelial cells

SL.NO

SEVERITY

GRADES

1

0-2

Grade 0

2

3-20

Grade 1

3

21-40

Grade 2

4

Above 40

Grade 3

Urine pus cells

SL.NO

SEVERITY

GRADES

1

0-5/hpf

Grade 0

2

5-15/hpf

Grade 1

3

15-25/hpf

Grade 2

4

25-35/hpf

Grade 3

Urine Bacteria

SL.NO

SEVERITY

GRADES

1

Absent

Grade 0

2

Present

Grade 1

DATA WILL BE COLLECTED AS FOLLOWS:

0th day -BT

On 15th day -AT

OVERALL ASSESSMENT:

Very Good Improvement - >75%

Good Improvement - 51-74%.

Moderate Improvement - 26-50%

Mild Improvement - <25%

No relief - 00