CTRI Number |
CTRI/2022/09/046006 [Registered on: 28/09/2022] Trial Registered Prospectively |
Last Modified On: |
28/09/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To know the effect of two varieties of enema pattern with Panchamoolabalasiddha Ksheera in Osteoarthritis |
Scientific Title of Study
|
“To evaluate the effect of Kashyapokta and Vagbhatokta Kala Basti with Panchamoolabalasiddha Ksheera in Janu Sandhigatavata - A Comparative Clinical Study†|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Tejali Rohidas |
Designation |
PG Scholar |
Affiliation |
Government Ayurveda Medical College Dhanwantari Road Bengaluru-560009 |
Address |
Second Year PG Scholar Department of Panchakarma
Government Ayurveda Medical College Dhawantari Road Bengaluru-560009
Bangalore KARNATAKA 560009 India |
Phone |
9108097076 |
Fax |
|
Email |
tejalirohidas@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sangnor Smita Laxmanrao |
Designation |
Professor |
Affiliation |
Government Ayurveda Medical College Dhanwantari Road Bengaluru-560009 |
Address |
Professor
Department of Panchakarma
Government Ayurveda Medical College Dhawantari Road Bengaluru-560009
Bangalore KARNATAKA 560009 India |
Phone |
9035869088 |
Fax |
|
Email |
drsmitaghule148@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sangnor Smita Laxmanrao |
Designation |
Professor |
Affiliation |
Government Ayurveda Medical College Dhanwantari Road Bengaluru-560009 |
Address |
Professor
Department of Panchakarma
Government Ayurveda Medical College Dhawantari Road Bengaluru-560009
Bangalore KARNATAKA 560009 India |
Phone |
9035869088 |
Fax |
|
Email |
drsmitaghule148@gmail.com |
|
Source of Monetary or Material Support
|
Government Ayurvedic Medical College and Hospital,Bangaluru-560009 |
|
Primary Sponsor
|
Name |
DrTejali Chandrakant Rohidas |
Address |
Second Year PG Scholars
Department of Panchakarma
Government Ayurveda Medical College, Dhanwantari Road, Bengaluru-560009 |
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 Tejali Chandrakant Rohidas |
Government Ayurveda Medical and Hospital ,Bengaluru |
OPD NO-6,IPd and camps
Department of PG Studies in Panchakarma
Government Ayurveda Medical college and Hospital, Bengaluru-09 Bangalore KARNATAKA |
9108097076
tejalirohidas@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Government Ayurveda medical college Institutional Ethical committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | kAla-bastiH, काल-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Astanaga Hridaya, Procedure details: Vagbhatokata kala basti (Group -A)
Poorva Karma-
1.Deepanapachana with Hingvashtaka choorna 3gm BD with ushna jala until nirama lakshana.
2.Koshthashodhana with Gandharvahastadi taila.
3.Sthanika Abhyanga with Ksheerbala taila followed by Bashpa Sweda.
4.Laghubhojana before Anuvasana prayoga.
Pradhana Karma-
1.PanchamoolabalasiddhaKsheera in Kala Basti schedule.
2.Dose:480ml
3.Anuvasana Basti with Guggulu Tiktaka Ghrita.
Paschat Karma-
1.After Niruha Basti pratyagamana ushna jala s) (1) Medicine Name: Panchamoolabalasiddha ksheera, Reference: Gadanigraha,Chakradatta, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 480(ml), Frequency: od, Duration: 5 Days(2) Medicine Name: Guggulu Tiktaka Ghrita, Reference: Astanga Hridaya , Route: Rectal, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Duration: 10 Days | 2 | Comparator Arm | Procedure | - | kAla-bastiH, काल-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Kashyapa Samhita, Procedure details: Kashyapokta Kala Basti (Group-B)
Poorva Karma-
1.Deepana pachana with Hingvashtaka choorna 3gm BD with ushna jala until nirama lakshana.
2.Koshthashodhana with Gandharvahastadi taila.
3.Sthanika Abhyanga with Ksheerbala taila followed by Bashpa Sweda.
4.Laghu bhojana before Anuvasana prayoga.
Pradhana Karma-
1.Panchamoolabalasiddha Ksheera in Kala Basti schedule.
2.Dose:480ml
3.Anuvasana Basti with Guggulu Tiktaka Ghrita
4.Dose: 60ml
Paschat Karma-
1.After Niruha Basti pratyagamana u) (1) Medicine Name: Panchamoolabalasiddhaksheera, Reference: Gadanigraha,Chakradatta, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 480(ml), Frequency: od, Duration: 3 Days(2) Medicine Name: guggulu Tiktaka Ghrita, Reference: Astanga Hridaya, Route: Rectal, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Duration: 12 Days |
|
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Subjects fit for Basti Karma.
2. Subjects diagnosed with Janu
Sandhigatavata.
3. Age-40-70yrs of either sex.
|
|
ExclusionCriteria |
Details |
1. Fracture of the knee joint.
2. Subjects with BMI >30.
3. Subjects with secondary OA.
4. Subjects with uncontrolled DM, HTN and
cardiac disease.
5. Malignant condition and congenital
deformity.
6. Pregnant and lactating women.
|
|
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 |
1.Sandhi shoola (pain)
2.Sandhisthabdhata (stiffness)
|
Before treatment on -0th day
After completion of treatment-on 10th day and 12th day.
Follow up on -36th day.
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Sandhishotha (swelling)
2.Crepitus
3.Akunchanaprasaranavedana (Goniometer)
4.WOMAC Scale
5.Waking time |
1.Before treatment on - 0th day.
2.After completion of treatment-10th and 12th day
3.Follow up on-36th day |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
01/10/2022 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
In Panchakarma, Basti is considered as “Ardhachikitsa†in the management of disease. When Basti is administered, it reaches pakwashaya and removes dosha from all over the body.It is the best treatmentline for Asthyashrayaja vyadhi.As per Acharya Charaka, Basti is mentioned as Vataharanam shrestam.So it is helpful in vatajadiseases like Janu Sandhigatavata where vriddhi in Ruksha guna of vata and kshaya of shleshakakapha produces pain and stiffness of knee joint during movement. All Vatavyadhi requires shodhana along with brumhana line of treatment. Acharya Sushruta has mentioned that 9-11 Anuvasana Basti is required for vata predominant diseases.This is fulfilled by Kala Basti pattern of Acharya Kashyapa and Acharya Vagbhata.Janu Sandhigatavata is vatajavyadhi presented with symptoms of Sandhishoola,vatapurnadrutisparshashotha and prasaranaakunchana vedana.It has symptoms similar to osteoarthritis of knee in conventional science. OA is age related chronic degenerative disease characterized by deterioration of cartilage of joints that results in bone rubbing together and creating stiffness, pain and impairment in movement. Osteoarthritis is second most common rheumatological problem with prevalence of 22% to 39% in India. By 2025 India may become the osteoarthritis capital of the world with over 60 million cases. Almost all persons over the age 40 have some bodily transformation in weight bearing joints. And this prevalence of OA is increasing with age and risk factors.The treatment of osteoarthritis mainly focuses on pain management using NSAIDS, Topical Analgesics, corticosteroids injection and lastly joint replacement surgery. As OA is an inevitable part of ageing, there is no other satisfactory treatment. As long-term intake of oral medication has its own side effects, so to deal with chronic joint diseases Ayurvedic management seems to be the best. Panchamoolabalasiddha Ksheera is indicated in Vataja vikara. Acharya Charaka mentions that whatever the medicine indicated in particular disease can be used in the form of basti.Panchamoola (laghu panchamoola) contains tikta,madhura rasa pradhana dravyas having vataghna, brumhana, balavardhana property, which helps in samprapti vighatana of the disease. In present scenario Kala Basti mentioned by Acharya Charaka is widely practiced, while Kala Basti mentioned by Kashyapa and Vagbhata are usually not in practice, as in today’s era everyone has busy schedule, hence an attempt is made to evaluate the effect of these two patterns of Kala Basti having maximum number of Anuvasana Basti in minimum duration using Panchamoolabalasiddha Ksheera Basti in Janu Sandhigatavata. |