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CTRI Number  CTRI/2024/03/064579 [Registered on: 21/03/2024] Trial Registered Prospectively
Last Modified On: 19/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Calcaneal spur management in Ayurveda 
Scientific Title of Study   TO EVALUATE THE EFFECTIVENESS OF TREATMENT PROTOCOL AS PER ACHARYA SUSRUTA IN VATAKANTAKA 
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 P Priyanka  
Designation  PG Scholar 
Affiliation  Dr BRKR Govt. Ayurvedic Medical Colleg,Erragdda,Hyderabad 
Address  OPD no 5,Department of Panchakarma, DR BRKR Govt. Ayurvedic Medical College, Erragadda, Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  8522906261  
Fax    
Email  priyanka30p07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveen Kumar Madikonda 
Designation  Associate Professor 
Affiliation  Dr BRKR Government Ayurvedic Medical College and Hospital 
Address  OPD No.5,Department of Panchakarma, Dr BRKR Ayurvedic Medical College, Erragadda, Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  9491854040  
Fax    
Email  pkmadikonda@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Praveen Kumar Madikonda 
Designation  Associate Professor 
Affiliation  Dr BRKR Government Ayurvedic medical college and Hospital 
Address  OPD No. 5,Department of Panchakarma, Dr BRKR Govt. Ayurvedic Medical College, Erragadda, Hyderabad
OPD No. 5,Department of Panchakarma, Dr BRKR Govt. Ayurvedic Medical College, Erragadda, Hyderabad
Hyderabad
TELANGANA
500038
India 
Phone  9491854040  
Fax    
Email  pkmadikonda@gmail.com  
 
Source of Monetary or Material Support  
Dr BRKR Government ayurvedic Medical college, Hyderabad 
 
Primary Sponsor  
Name  Dr BRKR Govt Ayurvedic Medical College Hyderabad 
Address  Dr BRKR GOVT. AYURVEDIC MEDICAL COLLEGE,HYDERABAD-500038 
Type of Sponsor  Government 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 P Priyanka  Dr BRKR GOVT. AYURVEDIC COLLEGE AND HOSPITAL  OPD Room NO.5, Department of Panchakarma, Dr BRKR Govt. Ayurvedic Medical College, Hyderabad.
Hyderabad
TELANGANA 		 8522906261

priyanka30p07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Dr. B.R.K.R. Government Ayurvedic College ,Hyderabad. Affiliated to Kaloji Narayana Rao University of Health Sciences, Warangal.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M773||Calcaneal spur. Ayurveda Condition: VATAKANTAKAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Susrutha nidana 1/79, Procedure details: Application of lukewarm Kottamchukkadhi taila externally to the heel region for a period of 30mins in a circular mannaer.)
(1) Medicine Name: Kottamchukkadhi Taila, Reference: Sahasrayogam, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: bd, Duration: 14 Days
2Intervention ArmProcedure-snehapAna-karma, स्नेहपान-कर्म (Procedure Reference: Susrutha Chikitsa 4/8, Procedure details: Snehapana with Guggulu tiktha ghritham with a dosage of 20ml orally advised to take empty stomach in the morning for a period of 14days. )
(1) Medicine Name: Guggulu Tikta Gritham, Reference: Astanga Hridaya, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 14 Days
3Intervention ArmProcedure-upanAha-karma, उपनाह-कर्म (Procedure Reference: Susruta Chikitsa 4/8, Procedure details: Upanaha means bandhana or tie. Hot poultice of Kolakulutthadhi churna is applied to the heel region a period of 6-8hours.)
(1) Medicine Name: Kolakuluthadhi Churna, Reference: Astangasangraham, Route: Topical, Dosage Form: Churna/ Powder, Dose: 40(g), Frequency: od, Duration: 7 Days
4Intervention ArmProcedure-unmathana-karma, उन्मथन-कर्म (Procedure Reference: Susrutha nidana 4/8, Procedure details: Unamardana is done by using Kolakulutthadi churna by taking 30 gms of churna applied on the heel region by using certain amount of pressure in opposite direction for a period of 30 minutes.)
(1) Medicine Name: Kolakulutthadi Churna, Reference: Astangasangraham, Route: Topical, Dosage Form: Churna/ Powder, Dose: 30(g), Frequency: od, Duration: 7 Days
5Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Susrutha nidana 4/8, Procedure details: Agnikarma with Panchaloha shalaka is done by cleaning area with triphala kashaya and wiped with sterile gauze. Shalaka is made red hot then samyak bindu dagdha done at heel region. Simultaneously Kumani swaresa applied to minimise burning sensation then dusting with haridra done. Application of cow ghee at local part twice daily is advised.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient satisfying clinical features of Vatakantaka and Calcaneus spur.
1. Patients of Age group 20-70 years.
2. Patients who are fit for snehana, upanaha, Agni karma, bandhana and unmardana therapies as per classics 
 
ExclusionCriteria 
Details  Persons contra-indicated for Snehana, upanaha, bandhana, unmardana and Agnikarma according to classics.
1.Open wounds, fractures.
2.Allergic skin condition, inflammatory conditions like Rheumatoid arthritis, Gouty arthritis.
● Known case of hypertension, hypotension, diabetes mellitus, pregnancy, malignancy.
● Patients with HIV and HbsAG positive. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Providing Symptomatic relief for the patient.  Assessment done on baseline and after 7th week and 8th week day. 
 
Secondary Outcome  
Outcome  TimePoints 
To improve the quality of life of the patient.  Assessment done on baseline and after 45 days of treatment 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   30/03/2024 
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  
             Vatakantaka is a Vatapradhana vyadhi , particularly caused by walking on uneven surfaces which produces pain in khudakapradesha(heel), Acharya Susrutha explained this disease in nidana sthana. A calcaneal spur, or commonly known as a heel spur, occurs when a bony outgrowth forms on the heel bone.It can be located at the back of the heel (dorsal heel spur) or under the sole (plantar heel spur) .It is a painful disorder of ankle patients present with severe pain at plantar region which will be severe with the first steps on rising in the morning or following inactivity during the day.
            The main option in therapies, however aimed at symptomatic relief. Modern analgesics drugs are considered  as the first-line symptomatic treatment for calcaneal spur and and these medicines have undesirable effects. The use of panchakarma therapies becomes more popular to avoid the side effects of such drugs.
            Snehapana with Guggulu tiktha ghritam with a dosage of 20ml for 14 days advised to take internally. Application of lukewarm Kottamchukkadi oil externally to the heel region .Upanaha of Kolakulutthadi churna as hot poultice to the heel region for a period of 7 days. Unmardana is done by Kolakuluttha churna over the heel with certain amount of pressure in opposite direction for 30 mins over a period of 7 days. Heel bandage is advised to tie daily. Agnikarma plays very important role giving instant relief from pain. It has been described as the most effective therapy in the management of all painful conditions especially for musculoskeletal disorders. 
           The main option in therapies, however, aimed at symptomatic relief. This study is designed as single arm study in patients with Snehapana and Agnikarma. After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on Baseline  22nd , 32nd and 45th day  of treatment. This includes subjective assessment of  VAS score and duration of walking. The total duration of treatment be will be 45 days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
 
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