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CTRI Number  CTRI/2026/04/107746 [Registered on: 07/04/2026] Trial Registered Prospectively
Last Modified On: 03/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   Effect of panchatikta ksheer basti in asthisaushirya osteoporosis 
Scientific Title of Study   Comparative clinical trial to asses the efficacy of panchatikta ksheer yapan basti in the management of asthisaushirya ~osteoporosis in peri menopausal age group. 
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 Prajkta Jaywant Ingole 
Designation  PG Scholar 
Affiliation  CSMSS ayurveda mahavidyalaya and rugnalaya Aurangabad 
Address  OPD no.15 CSMSS Ayurveda mahavidyalaya and rugnalaya Kanchanwadi , Aurangabad , Maharashtra India 431011
OPD no.15 Panchakarma department CSMSS Ayurveda mahavidyalaya and rugnalaya Kanchanwadi , Aurangabad , Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India 
Phone  7410755017  
Fax    
Email  ingoleprajkta230898@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesh Dnyanoba Sonwane  
Designation  Proffessor 
Affiliation  CSMSS ayurveda mahavidyalaya and rugnalaya aurangabad 
Address  OPD no.15 CSMSS Ayurveda mahavidyalaya and rugnalaya Kanchanwadi , Aurangabad , Maharashtra India 431011
OPD no.15 Panchakarma department CSMSS Ayurveda mahavidyalaya and rugnalaya Kanchanwadi , Aurangabad , Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India 
Phone  9579773404  
Fax    
Email  ramesh10673@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prajkta Jaywant Ingole 
Designation  PG Scholar 
Affiliation  CSMSS ayurveda mahavidyalaya and rugnalaya Aurangabad 
Address  OPD no.15 CSMSS Ayurveda mahavidyalaya and rugnalaya Kanchanwadi , Aurangabad , Maharashtra India 431011
OPD no.15 Panchakarma department CSMSS Ayurveda mahavidyalaya and rugnalaya Kanchanwadi , Aurangabad , Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India 
Phone  7410755017  
Fax    
Email  ingoleprajkta230898@gmail.com  
 
Source of Monetary or Material Support  
CSMSS Ayurveda mahavidyalaya and rugnalaya Kanchanwadi , Aurangabad 431011 
 
Primary Sponsor  
Name  CSMSS Ayurveda mahavidyalaya and rugnalaya , Kanchanwadi Aurangabad  
Address  CSMSS Ayurveda mahavidyalaya and rugnalaya , Kanchanwadi Aurangabad 431011 
Type of Sponsor  Private medical college 
 
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 Prajkta Jaywant Ingole  CSMSS ayurveda mahavidyalaya and rugnalaya Aurangabad  OPD no.15 CSMSS Ayurveda mahavidyalaya and rugnalaya Kanchanwadi , Aurangabad , Maharashtra India 431011 OPD no.15 Panchakarma department CSMSS Ayurveda mahavidyalaya and rugnalaya Kanchanwadi , Aurangabad , Maharashtra India 431011
Aurangabad
MAHARASHTRA 		 07410755017

ingoleprajkta230898@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC CSMSS Ayurveda mahavidyalaya and rugnalaya   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M810||Age-related osteoporosis without current pathological fracture. Ayurveda Condition: ASTHIKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: ch.su 28/27, Procedure details: purvakarma 1.sarvang snehan will be done with til tail 2. sarvang swedan will be followed pradhan karma 1. subject will be asked to lie down on abhyangtable in left lateral position. 2.niruhabasti - panchatikta ksheer basti in bastiyantra , lubrication of anus will be done with til tail. 3. basti will be given by applying equal pressure on bastiputaka . paschatkarma 1. after bastidana, tadan of patient will be done 2. patient will be kept in supine position for few minutes. 3. pratyagaman will be observed )
(1) Medicine Name: panchatikta ksheer, Reference: ch.su 28/27, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 400(ml), Frequency: od, Duration: 8 Days
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: ch.su 28/27, Procedure details: (Procedure Reference: ch. su 28/27, Procedure details: purva karma 1. sarvang snehan will be done with til tail. 2. sarvang swedan will be followed after snehan pradhan karma 1. the patient will be asked to lie down on abhyanga table in left lateral position. 2.niruhabasti- Guduchi siddha ksheer basti taken in bastiyantra , lubrication of anus will be done with til tail. 3. basti will be given by applying equal pressure on bastiputak paschatkarma 1. after bastidana, tadan of patients must be done 2. patient will be kept in supine position for few minutes 3. pratyagaman should be observed ) (1) Medicine Name: Guduchi siddha ksheer , Reference: ch.su 28/27, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 400(ml), Frequency: od, Duration: 8 Days)
(1) Medicine Name: Guduchi siddha ksheer, Reference: ch. su 28/27, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 400(ml), Frequency: od, Duration: 8 Days
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  subject indicated for yapana basti sign and symptoms of asthisaushirya osteoporosis BMD value less than 2 5 sr calcium value 8 4 including MRS scale to rule out peri menopausal age 
 
ExclusionCriteria 
Details  traumatic infective endocrinal disorders etc which interfers with course of treatment patients contraindicated for yapana basti post hysterectomy subjects having menorrhagia etc 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduce asthitoda(pricking) and sandhishool(pain)  8 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduce sandhishool(joint pain) and sparsha asahyata(tenderness)  8 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)   14/04/2026 
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 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   Osteoporosis is defined as the reduced bone density , which causes a micro- architechtural deterioration of bone tissues and leads to an increased risk of fractures . the prevalence of osteoporosis increases with age reflecting the fact that the bone density declines with age, especially in women , the age realted decline in bone mass is accompanied by an increased risk of fractures . fractures realted to to osteoporosis are estimated to affect the 30% of women and 12% of men at some point in developed countries and are major public health problem . 
As per ayurveda , asthisaushirya can be considered as osteoporosis , there is diminished level of asthi itself , in ayurvedic text many herbal preparations are mentioned in management of asthisaushirya which are quite benefecial to treat .
Acharya Charak has explained basti as balaprada , said to be the ardha chikitsa and beneficial to vatavyadhis. it pacifies the imbalances caused by vata dosha in the whole body. 
panchatiksta ksheer basti as explained by charak sais that the tikta ras dravyas can be given to conditions like asthitoda , asthikshaya and asthisaushirya .
 
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