| CTRI Number |
CTRI/2025/01/078907 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Evaluate the effect of sugarcane on Mutrakshaya(oliguria) |
|
Scientific Title of Study
|
An evaluation of IKSHU MUTRAJANANAM SRESHTHAM W.S.R. to MUTRAKSHAYA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahima Gupta |
| Designation |
MD Scholar |
| Affiliation |
Shri NPA Govt. Ayurved College Raipur (C.G.) |
| Address |
Department of Kriya Sharir, Shri NPA Govt. Ayurved College Raipur (C.G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9174093057 |
| Fax |
|
| Email |
mahimag272@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gitanjali Sasmal |
| Designation |
Professor & HOD |
| Affiliation |
Shri NPA Govt. Ayurved College Raipur (C.G.) |
| Address |
Department of Kriya Sharir, Shri NPA Govt. Ayurved College Raipur (C.G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9407772981 |
| Fax |
|
| Email |
drgsasmal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Lecturer |
| Affiliation |
Shri NPA Govt. Ayurved College Raipur (C.G.) |
| Address |
Department of Kriya Sharir, Shri NPA Govt. Ayurved College Raipur (C.G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
7999723405 |
| Fax |
|
| Email |
drashokbhagat044@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri NPA Govt. Ayurved College Raipur (C.G.)492010 |
|
|
Primary Sponsor
|
| Name |
Office Of Principal Shri NPA Govt. Ayurved College Raipur (C.G.) |
| Address |
Shri NPA Govt. Ayurved College Raipur (C.G.) 492010 |
| Type of Sponsor |
Government medical college |
|
|
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 Mahima Gupta |
Shri Khudadad Dungaji Govt. Ayurved Hospital Raipur(C.G.) |
OPD No. 2 and 18, Speciality Clinic 1 and 2
Raipur
CHHATTISGARH |
9174093057
mahimag272@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Principal Shri NPA Govt. Ayurved College Raipur (C.G.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers Go through Assessment Criteria of Mutrakshaya |
| Patients |
(1) ICD-10 Condition:N399||Disorder of urinary system, unspecified. Ayurveda Condition: BASTIVYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saccharum officinarum, Reference: charak sutra 25, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject having the age group 16 – 40 years. (Madhyamavastha – vridddhi to sampurnta according to Acharya Sushruta)
2. Subjects showing the symptoms of Mutrakshaya, according to Ayurvedic text.
3. Selection of subjects irrespective of religion, socioeconomic status and marital status.
4. Subject who agrees to sign the consent form.
|
|
| ExclusionCriteria |
| Details |
1. Subjects age below 16 years and above 40 years.
2. Subject having Diabetes mellitus.
3. Any type of renal or urinary disease like renal calculi, chronic kidney disease, urinary obstruction, urinary tract disease.
4. Known case of AIDS, cancer, hepatitis.
•Subject who do not agrees to sign consent form.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A consuming Ikshu may lead to an improvement in mutrakshaya and enhance the overall health of the mutravaha srotas. This research aims to demonstrate that the nutrients and antioxidants present in Ikshu might be beneficial in controlling mutravaha srotas vikar. |
2 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is No effect of Ikshu on Mutrakshaya |
2 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| Date of Study Completion (India) |
01/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/07/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION-
Ayurveda,
an ancient Indian system of medicine, includes a profound understanding of
health and wellness, deeply intertwined with the rhythms of nature and the
universe. Rooted in the Vedic tradition, Ayurveda, or the ’Science of Life,’ is
not just about curse diseases; it’s a guide for living a balanced, harmonious
life.
The living body is composed of Dosha,
DhÄtu and Mala. They support the body like a root, which supports
the tree along with leaves, branches, flowers and fruits. The dosas are
three in number -VÄta, Pitta and Kapha, seven dhatus named
as – Rasa, Rakta, Mamsa, Meda, Asthi, Majja and Sukra and three malas
named as - Mutra, Purish and Sweda. After pakakriya of aahar
rasa with jatharagni, mutra and purisha are produced
as waste product.
The
function of mutra is maintenance of moisture around all cells, filling
of urinary bladder, removing waste products, regulating water and electrolyte
balance, controlling blood pressure, and assisting in the elimination of toxins
and excess substances from the body. In mutrakshaya less quantity of
urine with discoloration of urine is observed along with intense thirst and
dryness of mouth. Sometimes, it is voided with difficulty and discoloration or
with blood in it.
Ikshu which is commonly known as sugarcane, is a tall perennial grass
indigenous to tropical regions. It is distinguished by its thick, jointed stems
filled with sweet sap. It is riched in nutrients such as carbohydrates,
vitamins, and minerals.
Acharya Caraka described Ikshu as sreshtha mutrajanana.
Due to guru, snigdh guna, Madhura rasa and vipak and sheeta
veerya of Ikshu, it has best diuretic property. Besides this it has
cooling, rejuvenating and nutritive effects on the body.
NEED FOR THE STUDY –
· According
to Acharya Caraka, Ikshu is the best mutrajanana (diuretic) drug
and which increase the flow of urine.
· Due
to it’s guru, snigdha guna, madhura rasa and vipak and sheeta
veerya; Ikshu has the effect on mutravaha srotas as mutrajanana
(diuretic).
·
The frequency of mutrakshaya
widely varies depending on the clinical setting. In adults, the incidence is
about 1%. When diuretics are consumed, they can lead to significant loss of
potassium and magnesium, both of which are crucial for heart health. This
mineral depletion over time can cause risks, affecting not only potassium and
magnesium levels but also those of calcium, zinc, and other important minerals.
Ikshu is highly nutritious, having a rich content of phosphorus, calcium, iron,
magnesium, and potassium, making it a valuable addition to one’s diet.
· Ikshu is easily available and
cost-effective so it can be useful for all socio-economic groups. Top of Form
· |