| CTRI Number |
CTRI/2026/02/105076 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of Kshaara Basti
and Haritkyaadi Guggulu in the Management of Amavata (Rheumatoid
Arthritis) |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Evaluate the Efficacy of Kshaara Basti
and Haritkyaadi Guggulu in the Management of Amavata (Rheumatoid
Arthritis) w.s.r. to Inflammatory Biomarkers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Anil Bhardwaj |
| Designation |
Professor and Head |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra HP |
| Address |
room no.- 203 PG Department of Panchkarma RGGPGACH Paprola Tehsil Baijnath District Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7997100006 |
| Fax |
|
| Email |
anil5karma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anil Bhardwaj |
| Designation |
Professor and Head |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra HP |
| Address |
room no.- 203 PG Department of Panchkarma RGGPGACH Paprola Tehsil Baijnath District Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7997100006 |
| Fax |
|
| Email |
anil5karma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Shikha |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra HP |
| Address |
room no.- 701 PG Department of Panchkarma RGGPGACH Paprola Tehsil Baijnath District Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
6230991335 |
| Fax |
|
| Email |
komalshikha011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Govt. Ayurvedic Pharmacy Paprola, District Kangra, Baijnath Pharmacy Paprola District Kangra,Herbal garden and Herbarium, Research Institute in ISM, Joginder Nagar, District Mandi HP |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra 176115 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Anil Bhardwaj |
Rajiv Gandgi Post Graduate Ayurvedic College and Hospital Paprola |
Room No. 203 Depatment of Panchkarma Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Tehsil Baijnath District Kangra
Kangra
HIMACHAL PRADESH |
7997100006
anil5karma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (Human) Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P. 176115 India |
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 | Comparator Arm | Procedure | - | Basti Karma | (Procedure Reference: Charaka Sidhi 1/20-21, Procedure details: 1. Poorva Karma-
a. Sthanika Abhyanga - Brihat Saindhavaadi Taila
b. Swedana- Sthanika Vashp Swedana
2. Pradhana Karma
a. Kshaara Basti – Niruh (Kaala Kram)
b. Brihat Saindhavaadi Taila - Anuvaasana
3. Paschat Karma- Vital Monitoring.
)
(1) Medicine Name: Kshaara Basti, Reference: Chakradutta, Niruhadhikara, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 300(ml), Frequency: od, Duration: 16 Days | | 2 | Intervention Arm | Procedure | - | Basti Karm with Medicine | (Procedure Reference: Charaka Sidhi 1/20-21, Procedure details: 1. Poorva Karma-
a. Sthanika Abhyanga - Brihat Saindhavaadi Taila
b. Swedana- Sthanika Vashp Swedana
2. Pradhana Karma
a. Kshaara Basti – Niruh (Kaala Kram)
b. Brihat Saindhavaadi Taila - Anuvaasana
3. Paschat Karma- Vital Monitoring.
)
(1) Medicine Name: Kshaara Basti, Reference: Chakradutta, Niruhadhikara, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 300(ml), Frequency: od, Duration: 16 Days(2) Medicine Name: Haritkyaadi Guggulu, Reference: Brihat Nighantu Ratnaakar, Route: Oral, Dosage Form: Guggulu, Dose: 1000(mg), Frequency: tds, Duration: 16 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
i. Patient willing for the study and are ready to give their consent.
ii. Patient between the age group of 25 - 75 yrs irrespective of sex, race, religion, socio-economic status.
iii. Patient presenting with the clinical features of Amavata as mentioned in Madhava Nidana and in EULAR criteria.
iv. Patient fit for Basti Karma.
|
|
| ExclusionCriteria |
| Details |
i. Patients not willing for the study and do not give their consent.
ii. Patients below the age of 25 years and above 75 years of age.
iii. Patients not fit for Basti Karma.
iv. Patients suffering from uncontrolled Hypertension, uncontrolled Diabetes Mellitus, malignancy, osteoporosis, carpal tunnel syndrome, cardiovascular diseases, respiratory diseases.
v. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| fulfilment of subjective and objective criteria |
16 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect on quality of life of the subject |
16 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2026 |
| 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="0"
Months="9"
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
|
i would like to publish my research trial after completion as soon as possible. A total of 30 subjects will be studied in 2 groups. 15 study subjects will be managed by Kshaara basti with Haritkyaadi Guggulu and 15 subjects will be managed with Kshaara basti. The outcome will be analysed based on subjective and objective parameters with appropriate statistical tools. |