| 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 LÄká¹£Ädi cÅ«rna UtsÄdana in comparison with Udgharsana with Triphala cÅ«rna and
DhÄnyamla 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | utsAdanam, उतà¥à¤¸à¤¾à¤¦à¤¨à¤®à¥ | (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 | | 2 | Comparator Arm | Procedure | - | udGarShaNam, उदà¥à¤˜à¤°à¥à¤·à¤£à¤®à¥ | (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
|
|
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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 cÅ«rna, Triphala cÅ«rna and dhÄnyamla, Triphala cÅ«rna 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 utsÄdana, 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 utsÄdana in prameha no
studies on utsÄdana in DSPN are
available. Hence the present study has been planned to assess the efficacy of utsÄdana in DSPN. |