| CTRI Number |
CTRI/2022/01/039360 [Registered on: 12/01/2022] Trial Registered Prospectively |
| Last Modified On: |
11/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
STUDY TO FIND POSSIBLE IMPURITIES AND CHEMICAL CHANGES HAPPENING TO MEDICATED OIL AFTER AN AYURVEDIC PROCEDURE NAMED KAYASEKA |
|
Scientific Title of Study
|
IDENTIFICATION OF POSSIBLE IMPURITIES AND CHEMICAL
CHANGES OCCURRING IN KSHEERABALA TAILA USED FOR
KAYASEKA IN HEALTHY INDIVIDUAL USING GC-MS AND HPTLC |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PARVATHY V S |
| Designation |
PG SCHOLAR |
| Affiliation |
AMRITA SCHOOL OF AYURVEDA |
| Address |
DEPT OF PANCHAKARMA,
AMRITA SCHOOL OF AYURVEDA, AMRITAPURI, AMRITA VISWAVIDYA
PEETHAM, INDIA
Kollam
KERALA
690525
India |
| Phone |
9446953860 |
| Fax |
|
| Email |
parvathyvs@ay.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anandaraman P V |
| Designation |
Professor and Head of the Department |
| Affiliation |
Amrita Vishwa Vidyapeetham |
| Address |
Department of Panchakarma
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham
Clappana P.O
Vallikavu
Kollam
Kollam
KERALA
690525
India |
| Phone |
9495130595 |
| Fax |
|
| Email |
dr.ananthramsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Parameswaran Namboothiri |
| Designation |
Professor and Head of the Department |
| Affiliation |
AMRITA SCHOOL OF AYURVEDA |
| Address |
Department of Panchakarma Amrita School of Ayurveda Amritapuri
Amrita Vishwa Vidyapeetham India
Kollam
Kollam
KERALA
690525
India |
| Phone |
9496096694 |
| Fax |
|
| Email |
kpn@ay.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda, Amritapuri
Amrita Vishwa Vidyapeetham, India. |
|
|
Primary Sponsor
|
| Name |
PARVATHY V S |
| Address |
PG Scholar
Department of Panchakarma Amrita School of Ayurveda Amritapuri
Amrita Vishwa Vidyapeetham India |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| PARVATHY V S |
AMRITA AYURVEDA COLLEGE & HOSPITAL |
PANCHAKARMA THEATRE
DEPARTMENT OF PANCHAKARMA
AMRITA SCHOOL OF AYURVEDA
Kollam
KERALA |
9446953860
parvathy.vs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vata pradhana prakriti females in 40-50 years age group, with BMI in the range 18.5-24.9, without any illness and not on medication for 6 months |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kAyasekaH, कायसेकः | (Procedure Reference: Dharakalpa, Procedure details: 5 L of Ksheerabala taila will be used for Kayaseka for 7 days after obtaining proper signs of digestion. )
(1) Medicine Name: Ksheerabala Taila, Reference: Bhavaprakasa Samhita, Route: Topical, Dosage Form: Taila, Dose: 5000(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | kAyasekaH, कायसेकः | (Procedure Reference: Dharakalpa, Procedure details: 5 Litre of Tila taila will be used for Kayaseka for 7 days, after obtaining signs of proper digestion)
(1) Medicine Name: Tila taila, Reference: Bhavaprakasa, Route: Topical, Dosage Form: Taila, Dose: 5000(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Vata pradhana prakriti individual selected as per the ‘Prototype Prakriti Analysis Tool’
developed by Sanjeev Rastogi
2. Snehana arha
3. Swedana arha
4. Age- 40 to 50 years
5. Sex- Females
6. BMI: 18.5—24.9
7. Apparently healthy volunteers without any illness and not on medication for 6 months
8. Those who satisfy the above criteria and sign the informed consent. |
|
| ExclusionCriteria |
| Details |
lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To check the HPTLC profile of the fresh taila and observe the change on each day of usage up to 7 days.
2. To check the GC-MS profile of the fresh taila and observe the change after usage on the
3rd and 7th day respectively.
3. To identify the physical impurities in the oil after the treatment. |
1. HPTLC- DAY 0, DAY 1, DAY 2, DAY3, DAY4, DAY5, DAY6, DAY7
2. GCMS- DAY0,DAY3,DAY7, AFTER FILTRATION
3. PARAMETERS- DAY0, DAY3, DAY7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the changes occurring to the taila after treating with cost-effective filtration methods. |
after filtration |
|
|
Target Sample Size
|
Total Sample Size="2"
Sample Size from India="2"
Final Enrollment numbers achieved (Total)= "2"
Final Enrollment numbers achieved (India)="2" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/01/2022 |
| Date of Study Completion (India) |
30/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In Keraleeya Kriyakrama practices the taila is replaced every 3 rd day and on the 7 th day both taila is mixed and used. In this way, about 5L to 6L of taila is used during the course. This is one of the deciding factors for the increased cost of the procedure. Dhara kalpa advices use of fresh taila every day and is considered to be of superior grade. Using the same taila for three days is moderate, using it beyond three days or mixing the used and fresh taila is of inferior grade. If treatment is done for 7 days, Dhara kalpa advices the use of fresh taila for 3 days, again fresh taila is pursued for the next 3 days and on the 7 th day the oil used on the initial and later 3 days are mixed and used. These references focus on the need for change of taila during the course of treatment. This could be due to some physical impurities or chemical changes happening to the taila during the procedure. No studies are available till date which identifies the impurities that come into the used taila and chemical changes occurring in taila which point towards the need to replace the taila every day or every third day. Aim of this study is to find changes in the HPTLC and GC-MS profile of taila during the course of treatment, identifying the possible impurities, implementing methods for effective filtration thus paving way for reuse of the taila, without compromising the constituents. In this study, two healthy volunteers having vata pradhana prakriti and satisfying the inclusion and exclusion criteria will be selected from those who come for the ‘Sukhachikitsa’ at Amrita School of Ayurveda and Hospital. After that pachana and deepana with trikatu churna is done until obtaining the pakwa mala lakshana. This will be followed by subjecting one of the participants to kayaseka with ksheerabala taila and other with tila taila. For this about 5L of Ksheerabala taila will be obtained from Kottakkal Arya Vaidya Sala along with 5L Tila taila used in the preparation of Ksheerabala taila. The participants will be given kayaseka with 5L taila, as there is no replacement of taila on the 3rd day. So, for the entire duration of the procedure this taila is used. At the end of each day’s procedure, 50 ml of sample will be collected from the oil drained out of the droni. These samples will be sent to care keralam Ayurveda research centre Trissur for further assessments. The oil left after the entire procedure is also preserved to identify the changes occurring to the taila after treating with cost-effective filtration methods |