| CTRI Number |
CTRI/2025/02/080288 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to check effect of Balashatavaryadi Ksheerapaka in treating Gouty Arthritis (Vatarakta) |
|
Scientific Title of Study
|
A Randomized Open-labelled controlled clinical study to evaluate the efficacy of Balashatavaryadi Ksheerapaka in the management of Vatarakta with special reference to Gouty arthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Angolkar Rachana Satish |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
OPD No-5 Dept of PG Studies in Kayachikitsa Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore KARNATAKA
560082 India
Bangalore
KARNATAKA
560082
India |
| Phone |
8879373331 |
| Fax |
|
| Email |
drrachanaangolkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopalakrishna G |
| Designation |
Head of Department |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic
Science and Research Hospital 21st Km Kanakpura Rd Udayapura
PO OB Chudahalli Bangalore Bangalore KARNATAKA 560082 India
Bangalore
KARNATAKA
560082
India |
| Phone |
9448173128 |
| Fax |
|
| Email |
lakshmimp1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopalakrishna G |
| Designation |
Head of Department |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic
Science and Research Hospital 21st Km Kanakpura Rd Udayapura
PO OB Chudahalli Bangalore Bangalore KARNATAKA 560082 India
KARNATAKA
560082
India |
| Phone |
9448173128 |
| Fax |
|
| Email |
lakshmimp1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road,Udayapura Post,
Bangalore. Karnataka 560082 India |
|
|
Primary Sponsor
|
| Name |
Dr Angolkar Rachana Satish |
| Address |
Dept of PG Studies in Kayachitsa,Sri Sri College of Ayurvedic
Science and Research 21st KM , Kanakapura Road, Udayapura
post, Bengaluru-560082 Karnataka, India |
| Type of Sponsor |
Other [SELF] |
|
|
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 Angolkar Rachana Satish |
Sri Sri College of Ayurvedic Science and Research Hospital |
Department of PG
studies in Kaya
Chikitsa,21st KM
Kanakapura Road,
Udaypura Post,
Bengaluru Karnataka
Bangalore
KARNATAKA |
8879373331
drrachanaangolkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M10||Gout. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: BALASHATAVARYADI KSHEERAPAKA, Reference: ASHTANG HRDAYA CHIKITSA STHANA VATARAKTA CHIKITSA, Route: Oral, Dosage Form: Ksheerpaka, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: AMRITAADI KWATH, Reference: CHAKRADATTA VATARAKTA CHIKITSA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling 6 out of 12 criteria of the American College of Rheumatology. (30)
Serum uric acid level more than 7mg/dl in males and more than 6mg/dl in females.
Subjects willing to participate with written informed consent.
|
|
| ExclusionCriteria |
| Details |
• Subjects with Serum uric acid levels more than 12 mg/dl in both the genders
• Subjects diagnosed with other joint diseases
• Subjects with a history of trauma, fractured joint, surgical or diagnostic intervention with reference to affected joint(s) in the past 1 year.
• Subjects who are pregnant and lactating mothers.
• Subjects with any uncontrolled systemic illness including Diabetes mellitus, Hypertension and chronic kidney disease.
• Any other conditions interfering the course of treatment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in serum uric acid level and symptomatic relief |
0,15,30, 45 DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Generation of in depth analyzed data on the
different aspect of disease |
0,15,30, 45 DAY |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Vatarakta
is one of the painful joint disorders mentioned by Acharya Charak. It is
caused by the vitiation of Vata Dosha and Rakta Dhatu.
Vatarakta
resembles the symptomatology of gout which is caused by hyperuricemia.
Hyperuricaemia
is defined as a serum or plasma urate concentration greater than 7 mg/dL in
males and 6 mg/dL in females. Gout is an inflammatory response to the
monosodium urate monohydrate (MSUM) crystals formed secondary to
hyperuricaemia. (1)
The
incidence of gout varies in population from 0.2 to 3.5 per 1000, with an
overall prevalence of 2-26 per 1000. (1)
The clinical progression of gout can lead to
gouty arthritis, characterized by painful swelling and tenderness, usually of the
great toe and metatarsophalangeal joint. (2)
M10.00
is the ICD-10-CM code used for diagnosing Gouty arthritis. (3) ED-08
is the National Ayurveda morbidity code (NAMC) for Vatarakta. (4)
In
contemporary medicine, treatment for gouty arthritis includes non-steroidal
anti-inflammatory drugs (NSAID), Colchicine, Allopurinol, Febuxostat and
steroids. These drugs may cause adverse reactions like Dyspepsia,
hypersensitivity, headache, nausea and so on. Long-term use of NSAID is not
recommended due to the risk of toxicity (5)
Thus,
there is a need for an effective drug that will manage Gouty arthritis and
prevent related co-morbidities.
Balashatavaryadi
Ksheerapaka has Tikta Madhura predominant Rasa
and Madhura Vipaka which might help in Vata-Pitta Shamana
and reducing Shoola. Sheeta Virya of the formulation might
help in Dahaprashamana. Majority of the drugs are Shoolahara and Shothahara,
which is a predominant clinical symptom of Vatarakta. This formulation
contains drugs having anti-inflammatory and analgesic properties. (6) Hence,
Balashatavaryadi Ksheerapaka is taken as a trial drug to evaluate its
therapeutic efficacy in Vatarakta
Amritaadi Kwath is a proven drug for
the management of Vatarakta. It is Tridoshashamak, Dahaprashamak
and has anti-inflammatory properties. Hence it is taken as a control drug to
compare and establish its efficacy |