| CTRI Number |
CTRI/2014/08/004931 [Registered on: 26/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
22/08/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OF "IRUKAARA PARPAM" IN PATIENT WITH KIDNEY STONE |
|
Scientific Title of Study
|
A CLINICAL STUDY ON AZHAL KALLADAIPPU (RENAL CALCULI)AND THE DRUG OF CHOICCE IS IRUKAARA PARPAM (INTERNAL). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR B SIVARAJA MANICKAM |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPARTMENT OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI-47
TAMBARAM SANATORIUM CHENNAI47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9585695147 |
| Fax |
04422381314 |
| Email |
sivarajamanickam87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR T LAKSHMIKANTHAM |
| Designation |
LECTURER |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPARTMENT OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI 47
TAMBARAM SANATORIUM CHENNAI47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444466880 |
| Fax |
04422381314 |
| Email |
drlakshmiramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S MOHAN |
| Designation |
DEAN |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPARTMENT OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI47
TAMBARAM SANATORIUM,CHENNAI-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9443972173 |
| Fax |
04422381314 |
| Email |
drmohan139@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF SIDDHA |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
TAMBARAM SANATORIUM CHENNAI47 TAMILNADU |
| Type of Sponsor |
Research institution and hospital |
|
|
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 B SIVARAJA MANICKAM |
NATIONAL INSTITUTE OF SIDDHA,DEPARTMENT OF MARUTHUVAM,BRANCH I,OPD NO 1 |
TAMBARAM SANTORIUM CHENNA47
Kancheepuram
TAMIL NADU |
9585695147
04422381314
sivarajamanickam87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
AZHAL KALLADAIPPU(RENAL CALCULI), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IRUKAARA PARPAM |
IT IS A MINERAL FORMULATION,130Mg with HONEY,BID,ORAL ROUTE ADMINISTRATION,24days |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Patients who are having the classical symptoms of abdominal pain and distensión, pain from loin to groin, pain in urethra, agonizing pain, dysuria, oliguria, yellow coloured urination, burning micturition, haematuria, nausea and vomiting.
• Stone size: ≥4mm and ≤10mm
• Patient with renal calculus detected on X-ray KUB or USG abdomen.
• History of Recurrence of Renal calculi.
• Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 24days but can opt out of the trial of his/her own conscious discretion.
• Patients who are willing to take Ultrasonography Investigation (USG- abdomen / KUB) and provide blood and urine samples for laboratory investigation.
|
|
| ExclusionCriteria |
| Details |
• Stone size 10mm
• Pregnancy and lactation
• Presence of any associated severe systemic illness, e.g.CA
• Patient taking any other lithotriptic agent in the recent past
• History of Diabetes/ Hypertension
• Renal diseases
• Cardiac diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1complete clearance/ reduction in the size of renal calculus in X-ray KUB or USG abdomen. |
24 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. Complete reduction of clinical symptoms and improvement in the lab investigation |
24DAYS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/01/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
STILL NO PUBLICATION |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Renal calculus
or Nephrolithiasis is one of the most common diseases of the renal system. It
occurs more frequently in men than in women and in whites than in blacks. It is
rare in children. Urinary calculus
is a stone-like body composed of urinary salts bound together by a colloid
matrix of organic materials. It consists of a nucleus around which concentric
layers of urinary salts are deposited. Nephrolithiasis occurs
in all parts of the world, with a lower lifetime risk of 2-5 percentages in
Asia, 8-15 percentages in the West, and 20 percentages in Saudi Arabia.[9]. In India,the incidence of upper and lower urinary tract calculi
is more. With its multifactorial etiology and high rate of recurrence, urinary
tract stone disease becomes a medical
challenge. The new approach in diagnosis and management like Extra-corporeal
shock wave lithotripsy (ESWL) and endoscopy surgery are not cost effective to
the lower socio- economic groups, who are mostly affected by urinary calculus,[2]
when compared to the treatment with traditional system of medicine, which is
cost effective.its give me a motivation to do a study on IRUKAARA PARPAM in the
treatment of azhal kalladaippu. In the text Siddha vaithiya Patharthaguna
vilakkam-Thaathu Jeeva Vaguppu ‘IRUKAARA
PARPAM†a Siddha formulation has been specifically
indicated for kalladaippu. The mode of
preparation seems to be simple and cost effective.The main ingrediants of the above said formulation are vengaram (borax)
and padikaaram( alum). Vengaram(Borax) is well known for its karkaraichi(lithotriptic),Siruneer
perukki(diuretic) and Azhukalakatri (antiseptic) actions as per Siddha
literature[15]. Padikaaram (Alum) has Isivakatri(antispasmodic),Azhukalakatri(antiseptic)
and Kuruthi pokkadaki(haemostatic) actions as per Siddha literature[16].
The above said drug formulation
has not yet undergone any safety studies
and yet to be documented clinically. Hence I have selected the siddha
formulation “ IRUKAARA PARPAM†for further clinical evaluation in AZHAL
KALLADAIPPU. IRUKAARA PARPAM METHOD OF PREPARATION: INGREDIENTS:
- Purified Vengaram - 1palam(35gms)
- Purified Alum - 1palam(35gms)
- Lemon juice - Required quantity
- PURIFICATION OF TRIAL DRUGS:
- 1.Vengaram:
Purification will be done by
frying the Vengaram in a mud vessel until the water content evaporates.
Alum
will be mixed well with water and will
be filtered. The filtrate will be boiled again and allowed to cool. |