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CTRI Number  CTRI/2024/05/066718 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The study compares how well the Lakshadi curna and plain ghee massage (Utsadana)treats diabetic complication ( DSPN) against Triphala curna and Dhanyamla massage (Udgharsana). 
Scientific Title of Study   Effectiveness of Lākṣādi cÅ«rna Utsādana in comparison with Udgharsana with Triphala cÅ«rna and Dhānyamla in the management of Diabetic Distal Symmetric Polyneuropathy – A Pragmatic Randomized Controlled Clinical 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  Fahmitha Hanna C 
Designation  PG Scholar 
Affiliation  VPSV Ayurveda College Kottakkal 
Address  Department of Panchakarma, VPSV Ayurveda College, Kottakkal Malappuram

Malappuram
KERALA
676501
India 
Phone  8289830290  
Fax    
Email  fahmidaajmal94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jigeesh P P 
Designation  Professor & HOD 
Affiliation  VPSV Ayurveda College Kottakkal 
Address  Department of Panchakarma, VPSV Ayurveda College, Kottakkal, Malappuram

Malappuram
KERALA
676501
India 
Phone  9447997436  
Fax    
Email  drjigeesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jigeesh P P 
Designation  Professor & HOD 
Affiliation  VPSV Ayurveda College Kottakkal 
Address  Department of Panchakarma, VPSV Ayurveda College, Kottakkal, Malappuram

Malappuram
KERALA
676501
India 
Phone  9447997436  
Fax    
Email  drjigeesh@gmail.com  
 
Source of Monetary or Material Support  
Vaidyaratnam P.S Variers Arya Vaidya Sala Kottakkal ( P.O) Malappuram (Dist.) Kerala Pin- 676 503 (GMP certified institute)  
 
Primary Sponsor  
Name  VPSV Ayurveda College Kottakkal 
Address  VPSV Ayurveda College Kottakkal Edarikode PO Malappuram Kerala 676 501 
Type of Sponsor  Other [Aided 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 Fahmitha Hanna C  V P S V Ayurveda College Kottakkal  OPD Department of Panchakarma Room number A112
Malappuram
KERALA 
8289830290

fahmidaajmal94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee (IEC) Vaidyaratnam P S Varier Ayurveda College Kottakkal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: PRAMEHA-UPADRAVAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-utsAdanam, उत्सादनम् (Procedure Reference: Srikantha Murthy K.R Susruta Samhita Chikitsasthana. 51-54/24, Varanasi Chaukambha orientalia; 2014.p228 , Procedure details: 1. Ask the patient to sit on the droni with the legs well extended. 2. Ask the patient & therapist to wear mask 3. Take handful of cūrna and mix it with adequate drava dravya 4. Rub over body in pratiloma direction with moderate pressure starting from lower limbs 5. Apply mild pressure over bony prominences 6. Continue the procedure in seven postures (sitting, supine, right lateral, supine, left lateral, supine, sitting) for 45 minutes 7. Remove the medicine with a clean and dry tow)
(1) Medicine Name: Lakshadi utsadana curna, Reference: Sreeman Namboothiri. Chikitsa Manjari. Prameha chikitsa Alappuzha vidyarambham publishers;2019;p235- 236, Route: Topical, Dosage Form: Churna/ Powder, Dose: 250(g), Frequency: od, Duration: 14 Days
2Comparator ArmProcedure-udGarShaNam, उद्घर्षणम् (Procedure Reference: Srikantha Murthy K.R Susruta Samhita Chikitsasthana. 51-54/24, Varanasi Chaukambha orientalia; 2014.p228 , Procedure details: 1. Ask the patient to sit on the droni with the legs well extended. 2. Ask the patient & therapist to wear mask 3. Take handful of cūrna and mix it with adequate drava dravya 4. Rub over body in pratiloma direction with moderate pressure starting from lower limbs 5. Apply mild pressure over bony prominences 6. Continue the procedure in seven postures (sitting, supine, right lateral, supine, left lateral, supine, sitting) for 45 minutes 7. Remove the medicine with a clean and dry tow)
(1) Medicine Name: Triphala curnam, Reference: Vagbhata. Ashtangahrudayam Sutrasthanam. 9th ed. Sreekumar.T, ed. Varanasi:Chaukhamba Orientalia; 2007.6/159, Route: Topical, Dosage Form: Churna/ Powder, Dose: 250(g), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Participants fulfilling the diagnostic criteria
2.Aged 35 – 70 years
3.Gender- no discrimination
4.Participants who have given informed consent
 
 
ExclusionCriteria 
Details  1.Known cases of other peripheral neuropathy
2.Participants with hypersensitivity of skin, dust allergy
3.Clinical evidence of active cardiovascular, respiratory, renal and cerebrovascular diseases
4.Clinically significant orthopedic, muscular, thyroid and peripheral vascular disorders
5.Active Diabetic foot ulcers, infection and amputation of lower limbs
6.Presence of edema in lower limb
7.H/O use of sedative treatments, hypnotics, anticonvulsants in the past 7 days
8.Pregnant and lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Neuropathy Total Symptom Score 6
2. Quantitative sensory test – Biothesiometer
3. Semmes Weinstein Monofilament testing 
0th, 15th, 29th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Symptom scoring Based on Ayurvedic symptomatology
2. Quality of Life assessment by Brief Pain Inventory (SF) 
0th, 15th, 29th day 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   20/05/2024 
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)
Modification(s)  
Not Applicable 
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  

Polyneuropathy is a common and debilitating complication of Diabetes Mellitus, affecting more than half of all Diabetic patients. Currently available drugs are often ineffective and complicated by adverse events, hence treatments not entirely satisfactory. Considerable number of patients are seeking nonpharmacologic/alternative medical systems for their management19. DSPN is one of the most important research area in Ayurveda. Several panchakarma procedures have been studied and results are encouraging.A review of researches of external procedures in complications of prameha like DSPN shows that most of the studies focussed are on efficacy of rooksha procedures udvartana, assuming role of kapha in the pathology of prameha. There are studies showing the effect of udgharsana with Triphala cūrna, Triphala cūrna and dhānyamla, Triphala cūrna and taila in prameha or sthoulya. But textual references consider predominance of vata in DSPN. In addition to that extreme apatarpana is contraindicated in prameha by all acharya and which can give raise to mutra graha, ruja, gulma, kshaya etc24. Hence many authors consider snigdha mediated procedures. In utsādana, even though the medium is snigdha the mechanism of procedure is same as that of udvartana, rubbing in the upward direction. Thus it can be considered as an administration of snigdha in a controlled manner which will be more useful in complications of prameha. Even though there is textual indication for utsādana in prameha no studies on utsādana in DSPN are available. Hence the present study has been planned to assess the efficacy of utsādana in DSPN.

 
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