| CTRI Number |
CTRI/2020/03/024078 [Registered on: 19/03/2020] Trial Registered Prospectively |
| Last Modified On: |
25/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Rasnadi kwath ghan vati and Rasnadi guggul in Katigatvat( Katishool- Low backach) |
|
Scientific Title of Study
|
A randomized comparative clinical trial to evaluate the efficacy of Rasnadi kwath ghan vati with Rasnadi guggul in Katigatvat. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivkanta Laxman Chetlure |
| Designation |
PG Student |
| Affiliation |
PDEAs college of ayurved and research centre, Nigadi pradhikaran, Pune. |
| Address |
PDEAs college of ayurved and research centre, third floor, Kayachikitsa department,sector no 25,Nigadi Pradhikaran, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8975362848 |
| Fax |
|
| Email |
shivkantachetlure@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Khobragade |
| Designation |
Asso professor |
| Affiliation |
PDEAs college of ayurved and research centre, Nigadi pradhikaran. |
| Address |
PDEAs college of ayurved and research centre, third floor, Kayachikitsa department,sector no 25,Nigadi Pradhikaran, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivkanta Laxman Chetlure |
| Designation |
PG Student |
| Affiliation |
PDEAs college of ayurved and research centre, nigadi pradhikaran, pune. |
| Address |
PDEAs college of ayurved and research centre, third floor, Kayachikitsa department,sector no 25,Nigadi Pradhikaran, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8975362848 |
| Fax |
|
| Email |
shivkantachetlure@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurved and research center, nigadi pradhikaran,Pune44 |
|
|
Primary Sponsor
|
| Name |
Principal PDEAs college of ayurved and research centre |
| Address |
PDEAs college of ayurved and research centre,sector no 25,Nigadi Pradhikaran, Pune 44 |
| Type of Sponsor |
Private medical 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 Shivkanta Laxman Chetlure |
Ayurved rugnalaya and Sterling multispeciality hospital nigadi pradhikaran Pune |
Vitthal rukmini road sector no 27, kayachikitsa OPD no117,nigadi pradhikaran Pune
Pune
MAHARASHTRA |
8975362848
shivkantachetlure@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Rasnadi Guggul |
Rasnadi Guggul will be prepared by vatikalpana and will be given to patients orally 500 mg 2 Bd with koshnajal as anupan at vyanodan kal for 21 days and follow up will be taken on 7th,14th,21st day. |
| Intervention |
Rasnadi kwath ghan vati |
Rasnadi kwath ghan vati will be prepared by the kwath sankalpana firstly and then ghanvati will be prepared from kwath by vatikalpana. 500 mg 2 Bd will be given to patient orally with Erand tail (3ml) and ghrit (5ml) as anupan at vyanodan kal for 21 days and follow up will be taken on 7th,14th,21st day. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having 3 or more following symptoms since one month.
-katishool
-katigrah
-Sharshashatwa
-sputan
-akunchan prasaran vedana
2.patients of age between 30-60 years irrespective of gender.
3.X-ray of lumbar spine will be done to evaluate changes, if any. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from any known case of sever systemic disorders.
2.Known case of Rheumatoid arthritis, psoriatic arthritis, gouty arthritis, Systemic Lupus erthematosus.
3.Pots spine, Paralysis, neurological disorders.
4.Pregnant and lactating women.
5.Patients having congenital structural deformities.
6.Fractures of lumbar spine and any other traumatic injuries which needs sugical cure will be excluded. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Rasnadi kwath ghan wati 500mg 2 bd with Erand Tail(3ml)and Ghrit(5ml) as anupan at vyanodan Kal with Rasnadi guggul 500mg 2 bd with koshnjal as anupan at vyanodan kal in Katigatvat. |
21 days with follow up on 7th, 14th and 21st day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare and study efficacy of Rasnadi kwath ghan wati.
2.To compare and study efficacy of Rasnadi guggul.
3.To study adverse effects,if any. |
21 days |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
23/03/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
In the present era ,due to change in life style and jerking activities during travelling and sports, abnormal sitting postures causing pressure on spinal cord which leads to spinal pathologies. Katigatvata or katishool is co related with lumbago or low back pain. Low back pain is commonest clinical presentation in now days. Low back pain is experienced approximately in 60-80% of adults at some point in their life time.Anderson estimated that the annual worldwide low back pain incidence in adults is 15% and prevalence is 30%. As per Ayurveda kati is the main location of vata. If it is trated well all other vat vyadhis can be prevented and effective medicines for this are given in various Ayurvedic samhitas. Hence there is need of ayurvedic research. The main objective of this research is to provide consolidated report on traditional uses and comparison of effects of Rasnadi kwath ghan vati and Rasnadi guggul in katigat vata. Reference of Rasnadi kwath ghan vati is taken from Chikitsaarnav -vatvyadhichikitsaadhikar and Rasnadi guggul taken from Yogratnakar-karnarogadhikar. |