CTRI/2025/10/096254 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On:
21/10/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Efficacy of Panchatikta Ghrita Guggulu over Lakshadi Guggulu after Panchaprasrta Basti in management of Asthishosha (Osteoporosis)
Scientific Title of Study
A Randomised Controlled Clinical Trial to evaluate the efficacy of Panchatikta Ghrita Guggulu over Lakshadi Guggulu after Panchaprasrta Basti in management of Asthishosha (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
Dr NEHA SHARMA
Designation
MD Scholar, Department of Kayachikitsa
Affiliation
All India Institute Of Ayurveda
Address
Department of Kayachikitsa, 6th floor,Academic block, Block C, All India Institute Of Ayurveda,Gautampuri, Sarita vihar, Mathura road, New Delhi
New Delhi DELHI 110076 India
Phone
7780936826
Fax
Email
drnehasharma32@gmail.com
Details of Contact Person Scientific Query
Name
Dr JONAH S
Designation
Professor and Head Of Department
Affiliation
All India Institute Of Ayurveda
Address
Department of Kayachikitsa, 6th floor,Academic block, Block C, All India Institute Of Ayurveda,Gautampuri, Sarita vihar, Mathura road, New Delhi
New Delhi DELHI 110076 India
Phone
8589805246
Fax
Email
jonahdr@gmail.com
Details of Contact Person Public Query
Name
Dr JONAH S
Designation
Professor and Head Of Department
Affiliation
All India Institute Of Ayurveda
Address
Department of Kayachikitsa, 6th floor,Academic block, Block C, All India Institute Of Ayurveda,Gautampuri, Sarita vihar, Mathura road, New Delhi
New Delhi DELHI 110076 India
Phone
8589805246
Fax
Email
jonahdr@gmail.com
Source of Monetary or Material Support
All India Institute of Ayurveda
Primary Sponsor
Name
All India Institute of Ayurveda,
Address
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New
Delhi
Type of Sponsor
Research institution and hospital
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr NEHA SHARMA
All India Institute Of Ayurveda
Department of Kayachikitsa, OPD NO. 3, Ground floor, Hospital block, All India Institute Of Ayurveda, Gautampuri, Sarita vihar, Mathura road, New Delhi New Delhi DELHI
7780936826
drnehasharma32@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
AIIA INSTITUTIONAL ETHICS COMMITTEE
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: ASTHISOSHAH,
1.Subjects aged between the age group of 31 and 60 years.
2.Diagnosed case of Primary osteoporosis by BMD Test (T- score of less than or equal to -2.5)
3.Lakshanas of sAsthishosha - Asthi Shoola, Asthi Toda, Santat Ruka, Bhrama, Nakha Bhanga, Shrama, Raukshya, Aswapna.
4.Patients fit for basti
5.Informed written consent
ExclusionCriteria
Details
1.Patients on long-term medications such as Steroids and antiepileptics drugs.
2.Osteomalacia, Rickets, Genetic causes juvenile osteoporosis, Cushing syndrome, Marfan Syndrome,
3.Patient with uncontrolled diabetes mellitus, hypertension thyroid and parathyroid disorders.
4.Cancer Patients, Surgical Patients, Pregnant Women and Lactating mothers
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1.Changes in Bone Mineral Density (BMD) and Improvement in lakshana of Asthishosha - Asthi Shoola, Asthi Toda, Santat Ruka, Bhrama, Nakha Bhanga, Shrama, Raukshya, Aswapna.
baseline
after 50th day
Secondary Outcome
Outcome
TimePoints
1.Improvement in laboratory parameters- VIT-D, Serum calcium, CBC with ESR, Thyroid profile, Serum Parathyroid Hormone, KFT, LFT, Lipid Profile.
2.Improvement in quality of life related to osteoporosis using Quality of life scores with QUALEFFO-41 questionnaire developed by IOF.
baseline
after 50th day
Target Sample Size
Total Sample Size="54" Sample Size from India="54" 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)
15/12/2025
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 Applicable
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
RESEARCHQUESTION
Does the administration of Panchatikta Ghrita Guggulu followed by Panchaprasrta Basti, when compared to Lakshadi Guggulu with the same pre-procedure, result in greater clinical improvement in patients between 31-60 years with Asthishosha (Osteoporosis)?
HYPOTHESIS
There is difference in the efficacy of Panchatikta Ghrita Guggulu and Lakshadi Guggulu, when administered after Panchaprasrta Basti, in the management of Asthishosha (Osteoporosis)
NULL HYPOTHESIS (H0)
There is no significant difference in the efficacy of Panchatikta Ghrita Guggulu and Lakshadi Guggulu, when administered after Panchaprasrta Basti, in the management of Asthishosha (Osteoporosis).
ALTERNATE HYPOTHESIS(H1)
There is significant difference in the efficacy of Panchatikta Ghrita Guggulu and Lakshadi Guggulu, when administered after Panchaprasrta Basti, in the management of Asthishosha (Osteoporosis)
Inclusion criteria
Exclusion criteria
Subjects aged between the age group of 31 and 60 years.
Patients on long-term medications such as steroids and antiepileptics drugs.
Diagnosed case of Primary Osteoporosis by BMD Test (T score of less than or equal to -2.5)
Changes in Bone Mineral Density (BMD) and Improvement in lakshana of AsthishoshaAsthi Shoola, Asthi Toda, Santat Ruka, Bhrama, Nakha Bhanga, Shrama, Raukshya, Aswapna.
Secondary Outcome:
Improvement in laboratory parameters VIT D, Serum calcium, CBC with ESR, Thyroid profile, Serum Parathyroid Hormone, KFT, LFT, Lipid Profile.
Improvement in quality of life related to osteoporosis using Quality of life scores with QUALEFFO 41 questionnaire developed by IOF.
OPD/IPD wing of AIIA according to diagnostic criteria
Sampling Procedure
Probability
Sample Size
54 (27 in each group)
Number of Groups
2
Timing
Prospective
Intervention (Basti and Oral medications)
8 days and 6 Weeks
Follow up
4 Weeks
Review Period
Once in 2 weeks
DURATION OF STUDY
Basti administration period 8 days
Oral Medication Period 6 weeks
Follow Up Period 4 Weeks
Review Period Once in 2 weeks
Sample Size Minimum sample size is 27 in each group. Sample size will be increased as per feasibility or Stratified sampling and analysis will be considered .