| CTRI Number |
CTRI/2021/07/034569 [Registered on: 05/07/2021] Trial Registered Prospectively |
| Last Modified On: |
10/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Niruha Basti] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Adityapaka Guggulu and Basti(Enema) in Sandhigatavata(Osteoarthritis) |
|
Scientific Title of Study
|
A Clinical Study to evaluate efficacy of Adityapaka Guggulu and Dasamuladi Niruha Basti in Sandhigatavata |
| Trial Acronym |
ADITYABASTI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rachna Nigam |
| Designation |
Assistant Professor |
| Affiliation |
Government PG Ayurveda College and Hospital, Varanasi |
| Address |
Department of Kayachikitsa and Panchakarma, Government PG Ayurveda College and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8948732899 |
| Fax |
|
| Email |
rachananigam19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachna Nigam |
| Designation |
Assistant Professor |
| Affiliation |
Government PG Ayurveda College and Hospital, Varanasi |
| Address |
Department of Kayachikitsa and Panchakarma, Government PG Ayurveda College and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8948732899 |
| Fax |
|
| Email |
rachananigam19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachna Nigam |
| Designation |
Assistant Professor |
| Affiliation |
Government PG Ayurveda College and Hospital, Varanasi |
| Address |
Department of Kayachikitsa and Panchakarma, Government PG Ayurveda College and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8948732899 |
| Fax |
|
| Email |
rachananigam19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government PG Ayurveda College and Hospital, Varanasi |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurveda College and Hospital Varanasi |
| Address |
Government PG Ayurveda College and Hospital, Choukaghat, Varanasi |
| 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 |
| Dr K K Dwivedi |
Government PG Ayurveda College and Hospital, Varanasi |
Department of Kayachikitsa,Government PG Ayurveda College and Hospital,Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH |
9336913142
dwivedikk@rediffmail.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:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adityapaka Guggulu |
500 mg (2 tab) BD after meal if Pt. weight is 50 kg, if Pt. weight 50 kg, 2 Vati will be given 2 TDS. |
| Comparator Agent |
Adityapaka Guggulu and Dasamuladi Niruha Basti |
2 tab of Adityapaka guggulu are given to patients daily after meal along with Dasamuladi Niruha Basti are given for 2 months. |
| Intervention |
Dasamuladi Niruha Basti |
500 ml of Niruha Basti and 60 ml of Mahanarayan taila anuvasana Basti are given to Patients according to classical methords for 16 days. Two schedule of Basti are given at an interval of 1 month. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having the signs and symptoms of Sandhigatavata as described in Ayurvedic texts were selected for clinical trial.
2. Patients giving clinical history of Osteoarthritis.
3. The diagnosis will be confirmed by x-ray examination of the involved joint wherever possible. |
|
| ExclusionCriteria |
| Details |
1. Patients having any complications.
2. Patients having any other serious illness.(Diabetes mellitus, tuberculosis, hypertension, cancer etc.)
3. Patients having any other type of arthritis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain and all symptoms in sandhigata vata |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence of signs and symptoms. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/07/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Topic: Sandhigatavata Roga Par Adityapaaka Guggulu ka Chikitsiya Vishleshana
Journal: A Reviewed Journal of Vishwa Ayurved Parishad
ISSN - 0976-8300
Date- March-April 2022 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In this clinical Study, patients Suffering from Sandhigata vata were selected from OPD and IPD of Government PG Ayurveda College and Hospital, varanasi, 221002.Patients between age group 40-70 years, both gender, having clinical signs and symptoms of Sandhigatavata were kept in Inclusive Criteria Patients having any complications, serious illness like Diabetes mellitus, Tuberculosis, Hypertension etc were kept in Exclusive Criteria 90 patients were randomly assigned in 3 groups. In Group 1: 30 patients were administered with Adityapaka Guggulu in a dose of 500 mg (2 tab) Bd after food for 2 months. In Group 2: 30 patients were administered with Dasamuladi Niruha Basti for 16 days. Two schedules of Basti were given at an interval of 1 months for 2 months. In Group 3: 30 patients were administered with both Aditypaka guggulu and Dasamuladi Niruha basti for 2 months. Follow up was done after 15 days of completion of treatment. In this study, Hb%, ESR, and S. calcium showed
improvement in all three groups.
All three groups showed statistically highly significant
improvement in subjective parameters after therapy. But maximum improvement was
observed in Group 3 i.e. 50% patients, who were treated with Dasamuladi
Niruha Basti and Adityapaka Guggulu as
compared to Group 2 and Group 1 with 33.33% and 26.67% maximum improvement
respectively. |