| CTRI Number |
CTRI/2024/10/074998 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Brimhana Basti and Shatavari Taila Nasya Karma in Asthikshaya (Osteoporosis). |
|
Scientific Title of Study
|
Clinical Study of Brimhana Basti and Shatavari Taila
Nasya Karma In Asthikshaya with Special Reference to Post Menopausal Osteoporosis.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRNITIKA PRASAD |
| Designation |
MD SCHOLAR |
| Affiliation |
GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL VARANASI |
| Address |
Department of Panchakarma, Government P.G. Ayurveda College and Hospital Varanasi
Department of Panchakarma, Government P.G. Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8433465765 |
| Fax |
|
| Email |
dr.nitikaprasad13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RACHNA NIGAM |
| Designation |
LECTURER ,PG DEPARTMENT OF PANCHAKARMA |
| Affiliation |
GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL VARANASI |
| Address |
Department of Panchakarma, Government P.G. Ayurveda College and Hospital Varanasi
Department of Panchakarma, Government P.G. 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 |
LECTURER ,PG DEPARTMENT OF PANCHAKARMA |
| Affiliation |
GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL VARANASI |
| Address |
Department of Panchakarma, Government P.G. Ayurveda College and Hospital Varanasi
Department of Panchakarma, Government P.G. Ayurveda College and Hospital Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8948732899 |
| Fax |
|
| Email |
rachananigam19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Government P.G. Ayurveda College and Hospital Varanasi, Uttar Pradesh (221002) |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL VARANASI |
| Address |
Department of Panchakarma, Government P.G. Ayurveda College and Hospital Varanasi |
| Type of Sponsor |
Government 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 Nitika Prasad |
Government P.G. Ayurveda College and Hospital |
Department of Panchakarma, Kayachikitsha Room No 8,11 Government P.G. Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH |
8433465765
dr.nitikaprasad13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL VARANASI U.P MAHAYOGI GURU GORAKHNATH AYUSH UNIVERSITY GORAKHPUR U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: ASTHIKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nAvanam, नावनमॠ| (Procedure Reference: CHAKRAPANI CHAPTER 12, Procedure details: SHATAVARI TAILA GIVEN BY NASAL ROUTE)
(1) Medicine Name: SHATAVARI TAILA , Reference: YOGRATNAKAR VATAVYADHI NIDANAM ADHYAY SHLOKA NO. 1-2, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: SUSHRUTA SUTRA 15/40, Procedure details: DECOCTION PREPARED GIVEN BY ANAL ROUTE)
(1) Medicine Name: MADHU ,SAINDHAV LAVANA ,GOGHRIT ,SHATPUSPHA KALKA , KSHEER, Reference: SUSHRUTA SUTRA 15/40, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 320(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Post menopausal females.
Patients presenting the classical symptoms of Asthi kshaya viz., Asthishool, Sandhi shaithilya, Asthi toda, Dourbalya, Sandhi shool, Asthi soushirya etc.
History of less than 1 yr.
•Patients voluntarily willing to participate in the trial.
|
|
| ExclusionCriteria |
| Details |
•Patient not fitting in the criteria of Basti karm.
•Patients not fitting in the criteria of Nasya karm.
•History of other active inflammatory or rheumatic disease, gouty arthritis.
•Severe articular inflammation as confirmed by physical examination.
•Morbidity other than Asthi kshaya.
•Patient age below 50yrs, menstruating female.
•Patient with severe hematological and hepatic, renal disorders, tuberculosis.
•Patients of Autoimmune joint disorder.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect on Osteoporosis |
30DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Increase the quality of life |
30 DAYS |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/06/2026 |
| 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 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
|
This study is an Interventional Open and Randomized Controlled Clinical Trial where review of relevant literature from Ayurvedic classics, modern medical science, Journals, previous researches and internet in great depth for conceptualization of etio-pathogenesis of Asthikshaya w.s.r. to PostMenopausal Osteoporosis and probable mode of action of Ayurveda drugs and procedures are taken. Patients will be randomly selected from the OPD/IPD of Department of Panchakarma, Government PG Ayurveda College and Hospital, Varanasi. 60 Patients will be studied under 2 groups having 30 patients in each group. Group
A- In this group each patient will be administered with Brimhana Basti for 30 days.
Group
B- In this group each patient will be administered with Shatavari taila Nasya for 30 days. |