| CTRI Number |
CTRI/2023/06/053955 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Lakshadi Guggulu Siddha Ghruta with & without Upanah in the management of Janu Sandhigata Vata (Osteoarthritis of knee joint).
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Scientific Title of Study
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An open labelled randomized comparative clinical study of Lakshadi Guggulu Siddha Ghruta with & without
Upanah in the management of Janu Sandhigata Vata (Osteoarthritis of knee joint).
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Urvashiben Kishanbhai Makhesana |
| Designation |
PG scholar |
| Affiliation |
Government Akhandanand Ayurved College and Hospital |
| Address |
OPD NO 4, Department of Kayachikitsa, Government Akhandanand Ayurved College, Bhadra, Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9737660241 |
| Fax |
|
| Email |
urvashipatel294@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himanshu Kanzaria |
| Designation |
Lecturer |
| Affiliation |
Government Akhandanand Ayurved College and Hospital |
| Address |
OPD No 4, Deparment of Kayachikitsa, Government Akhandanand Ayurved College, Bhadra, Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
8866579316 |
| Fax |
|
| Email |
drhimen2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshu Kanzaria |
| Designation |
Lecturer |
| Affiliation |
Government Akhandanand Ayurved College and Hospital |
| Address |
OPD No 4, Deparment of Kayachikitsa, Government Akhandanand Ayurved College, Bhadra, Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
8866579316 |
| Fax |
|
| Email |
drhimen2006@gmail.com |
|
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Source of Monetary or Material Support
|
| Governement Akhandanand Ayurved College, Ahmedabad |
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Primary Sponsor
|
| Name |
Government Akhandanand Ayurveda College |
| Address |
OPD NO 4, Department of Kayachikitsa, Government Akhandanand Ayurved college, Ahmedabad |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Urvashi K Makhesana |
Government Akhandanand Ayurved Hospital |
OPD No.4, Department of Kayachikitsa, Government Akhandanand Ayurved College, Bhadra, Ahmedabad
Ahmadabad
GUJARAT |
9737660241
urvashipatel294@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Lakshadi guggulu siddha ghruta, Reference: NA, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -warm milk), Additional Information: - | | 2 | Comparator Arm | Procedure | - | upanAhasvedaH (sAgniH, उपनाहसà¥à¤µà¥‡à¤¦à¤ƒÂ (सागà¥à¤¨à¤¿à¤ƒ) | (Procedure Reference: ch.su.14.35, Procedure details: 1 time per day for 1 month)
(1) Medicine Name: Tila tail,yav,godhuma,kinva,kanji,saindhav, Reference: ch.su.14/35, Route: Topical, Dosage Form: Lepa Churna, Dose: 460(g), Frequency: od, Duration: 1 Months |
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Inclusion Criteria
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| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with the classical signs and symptoms of Sandhigata Vata (OA) according to Ayurveda as well as Modern science will be taken into consideration like
Vatpurna Druti Sparsh Shotha
Akunchan Prasarne Vedana
Sandhi Shoola
Stiffness
Crepitus
Patients of age ≥30 to ≤70 years.
Chronicity less than 10 years
Degenerative changes |
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| ExclusionCriteria |
| Details |
Visible OA deformity
Chronicity more than 10 years
Dyslipidemia
Generalize anasarca
Serious systemic illness i.e. CKD, IHD, Metabolic syndrome etc.
K/C/of – RA, Trauma ,Gout, SLE, Infective arthritis, Psoriatic arthritis etc. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
By observing clinical improvement in signs and symptoms of disease and assess the effect of therapy objectively.
|
1 month |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To improve quality of life |
1 month |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2023 |
| Date of Study Completion (India) |
16/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Prakruta Vayu is responsible for all the activities of the body whereas Prakrupita Vata leads to many diseases. When Prakrupita Vata gets lodged in the Sandhis , it leads to the disease Sandhigata Vata .Janu sandhigata Vata is most common in Sandhigata Vata. Acharya Charaka has described the disease separately with the name of “Sandhigata Vata†under Vata Vyadhi with symptoms as-Vata purna druti sparsha, Shotha, Prasaran akunchan pravruti Savedana. Janu Sandhi is the major weight bearing joint in the body.Vata Prakopa and Kapha kshaya leads to Janu Sandhigata Vata. In modern science osteoarthritis is most common arthritic condition and is similar to Sandhigata Vata which is degenerative in nature. It is characterized by degeneration of joint cartilage and adjacent bones that cause joint pain and stiffness. It is slowly progressive disease. As in Bhava prakash Samhita the treatment protocol of Sandhigata Vata adopted can be grouped as Daha, Sneha and Upanah . Ghruta has a property such as Yogavahi , which is helpful in increasing the bioavailability of other drugs without losing its own property and Lakshadi Guggulu is indicated in Asthiruja, bhagna and Shoola . So, here Lakshadi Guggulu Siddha Ghruta has been selected. Among different types of Vata Upakrama, Upanah Swedana is described for the treatment of Sandhigata Vata. Here the use of Upanah as Swedana Karma may provide effective in subsiding Vata . Hence for quick relief from symptoms and early mobility of the patients, which is the main purpose of this study,Upanah Swedana has been selected for comparative study. DIAGNOSTIC CRITERIA Vatpurna Druti Sparsha Sotha (knee joint swelling) Akunchan Prasarne Vedana (Difficulty in flexion and extension of knee joint) Sandhi Shoola (Knee joint pain) Knee joint Stiffness Crepitus
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