| CTRI Number |
CTRI/2025/08/093912 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Navaka Guggulu and Vatari Guggulu in the management of Amavata(one type of joint disorder). |
|
Scientific Title of Study
|
A Ramdomized comparative clinical trial to evaluate the efficacy of Navaka Guggulu and Vatari Guggulu in the management of Amavata with special refrence to Rheumatoid Artritis. |
| 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 Adinath Vishnu Vetal |
| Designation |
Pg Scholar |
| Affiliation |
ShivaTrusts Yashwantrao Chavan Ayurvedic Medical College And Hospital |
| Address |
Department of Kayachikitsa 4th Floor Shiva Truts Yashwantrao Chavan Ayurvedic Medical College And Hospital Nipani Bhalgaon Chhtrapati Sambhajinagar (Aurangabad)
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
8668206291 |
| Fax |
|
| Email |
adinathvetal6235@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arshadkhan Pathan |
| Designation |
Associate Professor |
| Affiliation |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital |
| Address |
Department of Kayachikitsa 4th Floor Shiva Truts Yashwantrao Chavan Ayurvedic Medical College And Hospital Nipani Bhalgaon Chhtrapati Sambhajinagar (Aurangabad)
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9096577523 |
| Fax |
|
| Email |
arshupathan78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arshadkhan Pathan |
| Designation |
Associate Professor |
| Affiliation |
SHIVA TRUSTS YASHWANTRAO CHAVAN AYURVEDIC MEDICAL COLLEGE AND HOSPITAL CHH. SAMBHAJINAGAR |
| Address |
Department of Kayachikitsa 4th Floor Shiva Truts Yashwantrao Chavan Ayurvedic Medical College And Hospital Nipani Bhalgaon Chhtrapati Sambhajinagar (Aurangabad)
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9096577523 |
| Fax |
|
| Email |
arshupathan78@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital |
| Address |
Nipani-Bhalgaon Near Videocon comp ltd Beed Highway Chhatrapati Sambhajinagar(Aurangabad)Maharashtra 431005 |
| Type of Sponsor |
Private 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 Adinath Vishnu Vetal |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital |
Department of Kayachikitsa 4th Floor Shiva Truts Yashwantrao Chavan Ayurvedic Medical College And Hospital Nipani Bhalgaon Chhtrapati Sambhajinagar (Aurangabad)
Aurangabad
MAHARASHTRA |
08668206291
adinathvetal6235@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 |
(1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Navaka Guggulu, Reference: Yogratnakar Vidyotini Hindi Tika VD Shrilakshmipati Shastri Ayurved acharya Chaukhamba Prakashan Varanasi Edition Reprinted 2018 Uttarardh page 99 Navaka Guggulu Shlok 1, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshnajal), Additional Information: Ingredients 1.Shunthi-1Part 2.Maricha-1Part 3.Pippali-1Part 4.Chitraka-1Part 5.Mushta-1Part 6.Vidanga-1Part 7.Haritaki-1Part 8.Bibhitaki-1Part 9.Amalaki-1Part 10.Guggulu-9Part | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vatari Guggulu, Reference: Bhaisajyaratnavali By Kaviraj Sri Ambikadatta Sastri Ayurvedacarya Chaukhamba Prashan Varanasi Edition 2022 page 625 Shlok 152 153 154, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshnajal), Additional Information: Ingredients
1.Erand-1Part
2.Guggulu-1Part
3.Gandhaka-1Part
4.Haritaki-1Part 5.Bibhitaka-1Part
6.Amlaki-1Part |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The patients of age group 16 to 70 years will be selected.
Patients having the classical signs and symptoms of Amavata.
Patients will be selected irrespective of sex, Religion, occupation, Economical
status. |
|
| ExclusionCriteria |
| Details |
1. Amavata Upadravas like Tivra Jwara, hrudgraha , Bhrama.
2. Garbhini , lactating mother.
3. Any other major illness like HTN, AIDS, TB, DM, Malignancy, chronic alcoholism,
HbSAG positive, and other life treating conditions.
4. Patients suffering from Amavata more than 5 years.
5. The patients who have deformities like ulnar deviation , swan neck deformities,
ankylosis of wrist and elbow.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Navaka Guggulu in the management of Amavata with special reference to Rheumatoid Arthritis |
Follow-up on 7th,14th,21st,28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Navaka Guggulu & Vatari Guggulu in the management of Amavata with special reference to Rheumatoid Arthritis |
follow-up on 7th,14th,21st,28th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
08/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/09/2025 |
| 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 Yet Recruiting |
| 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
|
Even with the tremendous advancements in contemporary biomedical science, the
range of therapeutic interventions is still restricted. A class of diseases known as
rheumatological disorders lacks a specific medical treatment in any kind of pathy.
With prevalence of 0.8% in India[4], rheumatoid arthritis (RA) is the most prevalent
kind of autoimmune inflammatory arthritis. Without a question, the allopathic
medical system plays a significant role in treating arthritic pain and limited mobility.
Non Steroidal Anti inflammatory Drugs and Disease Modifing Anti Rheumatic Drugs
are medications that are used to treat inflammation-related symptoms. However,
these drugs may have some side effects such as hepatic and renal complications and
bone suppression, while the majority of Non Steroidal Anti inflammatory Drugs have
gastrointestinal adverse effects. Several Ayurvedic texts describe using numerous
drugs for the management of Amavata.
Navaka Guggulu mentioned in Yogaratnakar and Vatari Guggulu mentioned in
Bhaisajya Ratanavali are formulations described having theurapeutic indications in
Amavata.
Several scientific work’s are been done to study Amavata from Ayurvedic Samhita’s.
On the other hand there is no any prior comparative study done to know the
efficiency of Navaka Guggulu and Vatari Guggulu in Amavata. This main analytic
characteristic can improve valuable involvement to the present knowledge of
Amavata.
Considering this, the study is planned as A RANDOMIZED COMPARATIVE CLINICAL
TRIAL TO EVALUATE THE EFFICACY OF NAVAKA GUGGULU AND VATARI GUGGULU
IN THE MANAGEMENT OF AMAVATA WITH SPECIAL REFERENCE TO RHEUMATOID
ARTHRITIS. |