CTRI Number |
CTRI/2017/03/008096 [Registered on: 15/03/2017] Trial Registered Prospectively |
Last Modified On: |
05/03/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Clinical study for the management of Urolithiasis |
Scientific Title of Study
|
CliniHajarulayahuda Bhasma in the mancal Evaluation of Shvadamshtradi Kashaya and agement of Mutrashmari (Urolithiasis) |
Trial Acronym |
Shvadamshtradi Kashaya, Hajarulayahuda Bhasma |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr T Maheswar |
Designation |
Research Officer (Ayurveda) |
Affiliation |
CCRAS |
Address |
Regional Ayurveda Research Institute for Skin Disorders
New Rajiv nagar
Payakapuram
Vijayawada
Krishna ANDHRA PRADESH 520015 India |
Phone |
9441415266 |
Fax |
|
Email |
mahesh_rri@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr T Maheswar |
Designation |
Research Officer (Ayurveda) |
Affiliation |
CCRAS |
Address |
Regional Ayurveda Research Institute for Skin Disorders
New Rajiv nagar
Payakapuram
Vijayawada
ANDHRA PRADESH 520015 India |
Phone |
9441415266 |
Fax |
|
Email |
mahesh_rri@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr T Maheswar |
Designation |
Research Officer (Ayurveda) |
Affiliation |
CCRAS |
Address |
Regional Ayurveda Research Institute for Skin Disorders
New Rajiv nagar
Payakapuram
Vijayawada
ANDHRA PRADESH 520015 India |
Phone |
9441415266 |
Fax |
|
Email |
mahesh_rri@yahoo.co.in |
|
Source of Monetary or Material Support
|
Central Council for Research in Ayurvedic Sciences
JLNBCEH Anusandhan Bhawan
Institutional Area
Opposite D Block
Janak puri
New Delhi - 58 |
|
Primary Sponsor
|
Name |
Central Council for Research in Ayurvedic Sciences |
Address |
Jawahar lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan
61-65, Institutional Area,
Opposite D-Block,
Janakpuri, New Delhi - 110058
|
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr T Maheswar |
Regional Ayurveda Research Institute for Skin Disorders |
Regional Ayurveda Research Institute for Skin Disorders Room No 207, 3rd Floor
New Rajiv nagar
Payakapuram
Vijayawada Krishna ANDHRA PRADESH |
9441415266 08662402144 mahesh_rri@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Urolithiasis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Nil |
Nil |
Intervention |
Shvadamshtradi Kashaya and Hajarulayahuda Bhasma |
Shvadamshtradi Kashaya (Ref: Chakradatta, Asmari Chikitsa – 34/28)
Dose : 50 ml once a day
Dosage form: Decoction
Route of Administration: Oral
Time of Administration : Once a day before food
Duration of therapy:12 weeks
And
Hajarulayahuda Bhasma (Ref:AFI 14:4)
Dose : 500 mg bd
Dosage Form:Powder
Anupana :Luke warm water
Route of Adminstration : Oral
Time of Adminstration : Twice a day after food
Duration of Therapy:12weeks.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Patients of either sex with age between 18 and 60 years
2.Patients presenting with or without symptoms of urolithiasis.
3.Radiological evidence of calculi(upto 7 mm)
In kidney/ ureter /urinary bladder
|
|
ExclusionCriteria |
Details |
1.Age below 18 years and above 60 years
2.Calculi size more than 7 mm
3.Impacted calculi
4.Gross hydronephrosis, Pyelonephritis, Renal failure
5.Patients having serum creatinine >1.5 mg/dl
6.Patients who cannot report in person every 2 weeks in the OPD
7.Patients with poorly controlled Hypertension ( >160/100 mmHg)
8.Patients with poorly controlled Diabetes Mellitus having
Hb A1C of > 7.5%
9.Patients on medication with any other drugs that
may have an influence on the outcome of the study.
10.Known case of cardiovascular diseases
11.Known HIV positive cases
12.Patients with concurrent serious hepatic disorder
(defined as Aspartate Amino Transferase (AST) and / or
Alanine Amino Transferase (ALT), Total Bilirubin,
Alkaline Phosphatase (ALP) > 2 times upper normal limit),
Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and /
or Chronic Obstructive Pulmonary Disease [COPD]),
or any other condition that may jeopardize the study.
13.Alcoholics and/or drug abusers
14.H/o hypersensitivity to any of the trial drugs or their ingredients
15.Pregnant/lactating woman.
16.Patients who have completed participation in any other clinical trial during the past six months.
17.Any other condition which the Investigator thinks may jeopardize the study.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Radiological disappearance or reduction of calculi size |
12 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Relief in Signs & Symptoms of Mutrashmari |
12 weeks |
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/04/2017 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
Will be published after completion of the study |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
In Ayurveda Asmari (Urolithiasis) is well described in Charaka, Susrutha Samhitha with its etiopathogenesis, clinical features, type and prognosis. Vagbhata explained ashmari as one of the Asta maha gada. Asmari has been derived from the “Asman†Sanskrit word which literally means a structure resembling stone. It has been described that due to unwholesome diet and living habits aggravated kapha reaches in urinary tract dries up and forms the calculus and suppression of urge to passing urine resulting in crystallization and precipitate into calculus formation. There is colicky pain in bladder, anorexia, dysuria, fever, physical lassitude, goat like smell in urine and an excruciating pain in the neck of the bladder, scrotum indicate the formation of the urinary calculus. In Vataja variety stone resembles dusky in colour, hard, irregular, rough, nodular and spiny like kadambha flower & Patient feels severe pain, difficulty in passing urine, flatulus and stool. In pittaja variety stone resembles Marking nut seed shape, Yellowish black, blood mixed, honey coloured and patient feels burning sensation, warm feeling over bladder and sucking type of pain. In kaphaja variety stone resembles madhuka puspa in colour, unctuous, large sized like hen’s egg & patient feels dysuria, prickling and incising pain and heaviness and cold sensation over bladder region. On this disease a series of clinical Research Trials have been conducted for the evaluation of certain medicinal preparations in different stages of the disease effectively with Hajarulayahuda Bhasma, Pashanabhedadi ghrita, Kulattadi yoga, Vvarunadi kwatha, Pashanabhedadi kwatha, Ashmari hara kwatha, gokshuradi guggulu etc. This study has been planned to evaluate the efficacy and safety of Shvadamshtradi Kashaya and Hajarulayahuda bhasma. These drugs will be given for 12 weeks. This study will be conducted at OPD of Regional Ayurveda Research Institute for Skin Disorders, Vijayawada. |