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CTRI Number  CTRI/2025/09/094088 [Registered on: 02/09/2025] Trial Registered Prospectively
Last Modified On: 13/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Siravyadana or bloodletting in heel pain 
Scientific Title of Study   Efficacy of Siravyadana in plantar fasciitis: a randomized, open-labeled, controlled trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pratap Shankar K M 
Designation  Research Officer (Ay.) 
Affiliation  National Ayurveda Research Institute for Panchakarma 
Address  Room No. 621, Dept of Ayurveda, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur

Thrissur
KERALA
679531
India 
Phone  9744824014  
Fax    
Email  kmpvarma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pratap Shankar K M 
Designation  Research Officer (Ay.) 
Affiliation  National Ayurveda Research Institute for Panchakarma 
Address  Room No. 621, Dept of Ayurveda, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur


KERALA
679531
India 
Phone  9744824014  
Fax    
Email  kmpvarma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pratap Shankar K M 
Designation  Research Officer (Ay.) 
Affiliation  National Ayurveda Research Institute for Panchakarma 
Address  Room No. 621, Dept of Ayurveda, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur


KERALA
679531
India 
Phone  9744824014  
Fax    
Email  kmpvarma@gmail.com  
 
Source of Monetary or Material Support  
National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur, Kerala - 679531, India 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  61-65, opp. D’ Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 
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 KM Pratap Shankar  National Ayurveda Research Institute for Panchakarma  Room no. 624, Dept of Ayurveda, Hospital section, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur
Thrissur
KERALA 		 9744824014

kmpvarma@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee,National Ayurveda Research Institute for Panchakarma  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M722||Plantar fascial fibromatosis. Ayurveda Condition: VATAKANTAKAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: Susrutha Samhita, Sarira Sthana 8/17, Procedure details: Siravyadana (two angula above the Kshipra Marma or the prominent vein in the dorsal venous network) - Baseline, week 2, week 4, week 6, week 8, week 10 & week 12)
(1) Medicine Name: Panchtiktaka Guggulu Ghrita, Reference: Astanga Hrdayam, Chikitsa Sthana : 21/57-60, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Duration: 12 Weeks
2Comparator Arm (Non Ayurveda)-Stretching & foot orthosesStretching (plantar fascia-specific and gastrocnemius/soleus stretching) and foot orthoses for 12 weeks. Panchatiktaguggulu ghrita 6 gms twice daily after food
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects with inferior heel Pain  
 
ExclusionCriteria 
Details  1. Chronic pain syndrome or lumbosacral radiculitis
2. Neurological conditions such as peripheral neuropathy, polyneuropathy & radiculopathy
3. Peripheral vascular disease that results in rest pain or intermittent claudication
4. Patients with foot and arch issues such as flat foot and high arch foot
5. Calcaneal stress fracture
6. Spondyloarthropathies, Rheumatoid arthritis
7. Osteomyelitis of calcaneum
8. Patients unfit for the procedure of Siravyadana
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Foot Function Index (FFI)   Baseline, week 2, week 4, week 6, week 8, week 10 & week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Change in thickness in plantar fascia assessed by high-resolution ultrasonography  Baseline & week 12 
Satisfaction with the result of the treatment   week 12 
Change in hs-CRP   Baseline & week 12 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 3 
Date of First Enrollment (India)   01/10/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Plantar fasciitis is one of the common foot conditions treated by healthcare providers. The condition affects 10% of the general population, among which 83% belong to active working adults.1 Higher prevalence rate is observed in women compared to men and in those with a body mass index >25kg/m2. Overuse injury due to repetitive strains causing micro-tears of the plantar fascia often causes plantar fasciitis. The condition is primarily a degenerative and noninflammatory. 3 Rest, ice after activity, oral or topical nonsteroidal anti-inflammatory drugs are used as first line treatment. Supportive treatments, including the plantar fascia-specific stretch, calf stretching, appropriate orthotics and night dorsiflexion splinting also help to reduce pain in plantar fasciitis. Local steroid injections to the plantar fascia provide effective short-term pain relief. Ultrasonography-guided focal extracorporeal shock wave therapy is useful for patients with chronic plantar fasciitis. 4,5

Plantar fasciitis closely resembles the condition “Vatakantaka” mentioned in Ayurvedic texts. According to Susrutha, walking on an uneven ground causes pain in the heel due to vata situated in the heels and that is known as “Vatakantaka”. 6 Further, he mentions Siravyadana as the main line of treatment for this condition. 7, 8

Reference:

  1. Nahin RL. Prevalence and Pharmaceutical Treatment of Plantar Fasciitis in United States Adults. J Pain. 2018 Aug;19(8):885-896.
  2. Lapidus PW, Guidotti FP. Painful Heel: Report Of 323 Patients With 364 Painful Heels. ClinOrthopRelat Res. 1965 Mar-Apr;39:178-86.
  3. Buchanan BK, Sina RE, Kushner D. Plantar Fasciitis. [Updated 2024 Jan 7]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK431073/
  4. Lim AT, How CH, Tan B. Management of plantar fasciitis in the outpatient setting. Singapore Med J. 2016 Apr;57(4):168-70; quiz 171. doi: 10.11622/smedj.2016069.
  5. Tahririan MA, Motififard M, Tahmasebi MN, Siavashi B. Plantar fasciitis. J Res Med Sci. 2012 Aug;17(8):799-804.
  6. Susrutha, Susruta Samhita, Singhal GD (editor), 2nd Ed., NidanaSthana. 1/79, Delhi: Chaukhamba Sanskrit Pratishthan; 2007, Vol.1, p. 511.
  7. Susrutha, Susruta Samhita, Singhal GD (editor), 2nd Ed., ChikitsaSthana. 5/23, Delhi: Chaukhamba Sanskrit Pratishthan; 2007, Vol.2, p. 213.
  8. Susrutha, Susruta Samhita, Singhal GD (editor), 2nd Ed., SariraSthana. 8/17, Delhi: Chaukhamba Sanskrit Pratishthan; 2007, Vol.2, p. 101.

 
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