| CTRI Number |
CTRI/2026/03/106966 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Randomized Control Trial] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare Effect of Ayurvedic Panchtikta Ksheer Basti and Bisphosphonates In Managing Osteoporosis |
|
Scientific Title of Study
|
A Randomized Controlled Trial To Evaluate The Efficacy Of Panchtikta Ksheer Basti And Bisphosphonates On Bone Resorption Marker CTX-1 In The Management Of 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 |
DrRavina |
| Designation |
PhD Scholar |
| Affiliation |
The Institute of Ayurved studies & Research |
| Address |
Room no 14-ground floor in Hospital Baba Khetanath Government ayurvedic college and Hospital, Patikara, Narnaul
Mahendragarh
HARYANA
123001
India |
| Phone |
8396952148 |
| Fax |
123001 |
| Email |
drravinayadav11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Mehta |
| Designation |
Professor HOD Panchkarma |
| Affiliation |
The Institute of Ayurved studies & Research |
| Address |
Room No 67 first floor Department of Panchkarma Shri Krishna Ayush University Umri Road SECTOR-8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8950375285 |
| Fax |
|
| Email |
drashishhmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRavina |
| Designation |
PhD Scholar |
| Affiliation |
The Institute of Ayurved studies & Research |
| Address |
Room no 14-ground floor in Hospital Baba Khetanath Government ayurvedic college and Hospital, Patikara, Narnaul
Mahendragarh
HARYANA
123001
India |
| Phone |
8396952148 |
| Fax |
123001 |
| Email |
drravinayadav11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Ayush University Kurukshetra Haryana Pincode- 136118 |
|
|
Primary Sponsor
|
| Name |
DrRavina |
| Address |
Panchkarma Department opd Division Baba Khetanath Govt Ayurveda college and Hospital Narnaul 123001 |
| Type of Sponsor |
Other [self funding] |
|
|
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 |
| DrRavina |
Baba Khetanath Government ayurvedic college and Hospital, Patikara, Narnaul |
Room no 14-ground floor in Hospital Baba Khetanath Government ayurvedic college and Hospital, Patikara, Narnaul
Mahendragarh
HARYANA |
08396952148
drravinayadav11@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:M818||Other osteoporosis without currentpathological fracture. Ayurveda Condition: MAJJAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: charak samhita sidhi sthana 3/23, Procedure details: Basti will be prepared by madhu, sneha & ksheerpaka of tikta dravy. 480 ml basti will be administered through anal route for 15 days in 1st cycle & 15 days in 2nd cycle.After getting the urge patient will be asked to pass it without strain. Basti pratyagamana samyaka lakshana should be observed. )
| | 2 | Comparator Arm (Non Ayurveda) | | - | Alendronate | Alendronate (Bisphosphonate) Supplement 70 mg weekly once will be given through oral route. |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient representing with classical features of Asthikshaya
2 Patient of both sexes are taken
3 Patient of osteoporosis diagnosed by biomarker CTX-I (C-terminal cross linked
telopeptide)
4 Willingness to provide written informed consent and comply with study protocol
5 Patients fit for Basti |
|
| ExclusionCriteria |
| Details |
1 Patient below the age of 30 and above 60 years
2 Patient suffering from any systemic disorder like DM, HTN, Endocrinal disorders,
Paget’s disease, Cushing syndrome etc
3 Patient suffering from pathological osteoporosis or any neoplasm or osteoporosis
related to systemic disorders
4 Osteoporosis associated with fracture
5 Patients who were unfit for Basti karma
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the values of CTX-I (C Terminal Cross Linked Telopeptides)
|
90 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in parameters
1. Lakshanas of Asthi Kshaya
2. Lakshanas of Vatavriddhi
3. BMI
|
90 days |
BMI
Waist, Hip, Abdomen Circumference
VAS Scale
KOOS (Knee Injury and Osteoarthritis Outcome Score (KOOS).
MRI knee joint (if required)
|
90 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
18/05/2026 |
| 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="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
|
Osteoporosis is a chronic skeletal disorder characterized by low bone mass, deterioration of bone microarchitecture, and increased risk of fragility fractures. It is often referred to as a silent disease because bone loss occurs gradually without obvious symptoms until fractures occur. In Ayurveda Asthi- majja kshaya presents sign and symptoms that closely parallel to osteoporosis are asthishula, toda, sandhi shaithilya, kesha, loma, nakha, danta vikara, daurbalya, rukshata sparshashyatava.
Drug- 1. Bisphosphonates- 70mg weekly once through oral route purchased from Litnow Lifescience near pull bazar Narnaul. 2. Tikta ksheer Basti- 480 ml should be administered through rectal route for 15 days in 1st cycle and next 15 days in 2nd cycle prepared in BKNGAC & H.
Research Question: Does Tikta Ksheer Basti produce greater reduction in bone resorption marker serum CTX-I in osteoporosis. Null Hypothesis: There is no significant difference between Tikta Ksheer Basti and Bisphosphonate on bone resorption marker serum CTX-I in osteoporosis. Alternate Hypothesis: There is significant difference between Tikta Ksheer Basti and Bisphophonate on bone resorption marker serum CTX-I in osteoporosis.
Subjective Criteria- Detailed performa of Lakshans of Asthi Kshaya Detailed performa of Lakshans of Vata Vriddhi. Objective Criteria- i) BMI (ii) CTX-I (iii) VAS Scale (iv) KNOOS Score (v) MRI If required (vi) Waist hip circumference Expected Outcome -Anyone among Null and Alternate hypothesis will be outcome |