| CTRI Number |
CTRI/2025/09/094215 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [COMPARATIVE CLINICAL STUDY ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
SAHACHAR TAIL NASYA ALONG WITH ABHYANGA AND SAHACHAR TAIL NASYA IN THE MANAGEMENT OF MANYASTAMBHA. |
|
Scientific Title of Study
|
A Clinical Comparative Study Of Efficacy Of Sahachar Tail Nasya Along With Abhyanga And Sahachar Tail Nasya In The Management Of Manyastambha W.S.R To Degenerative Cervical Spondylosis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati jat |
| Designation |
Pg scholar Department of panchkarma |
| Affiliation |
|
| Address |
PG Department of panchakarma, OPD no.05,Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
7697723939 |
| Fax |
|
| Email |
swati1997.mani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati jat |
| Designation |
Pg scholar Department of panchkarma |
| Affiliation |
|
| Address |
PG Department of panchakarma, OPD no.05,Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
7697723939 |
| Fax |
|
| Email |
swati1997.mani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akansha haryani |
| Designation |
reader |
| Affiliation |
|
| Address |
PG Department of panchakarma, OPD no.05,Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
8770908291 |
| Fax |
|
| Email |
akansha.valecha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| PG Department of panchakarma Rani Dullaiya Smriti Ayurved PG Mahavidhyalaya Evam Chikitsalaya Barkhedi Kalan Bhadabhada Road,462044 Bhopal MP, india |
|
|
Primary Sponsor
|
| Name |
Rani Dullaiya Smriti Ayurved PG Mahavidhyalaya Evam Chikitsalaya bhopal mp |
| Address |
PG Department of panchakarma Rani Dullaiya Smriti Ayurved PG Mahavidhyalaya Evam Chikitsalaya Barkhedi Kalan Bhadabhada Road,462044 Bhopal MP, india |
| 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 Swati Jat |
Rani Dullaiya Smriti Ayurved PG Mahavidhyalaya Evam Chikitsalaya Bhopal MP |
PG Department of panchakarma room no. 5 Rani Dullaiya Smriti Ayurved PG Mahavidhyalaya Evam Chikitsalaya Barkhedi Kalan Bhadabhada Road Bhopal MP
Bhopal
MADHYA PRADESH |
7697723939
swati1997.mani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Rani Dullaiya Smriti Ayurved PG College And Hospital Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: SUSHRUT CHIKITSA 40/20, Procedure details: Patient will be lied down in comfortable supine position on table and head low position
will be made with the help of pillow. Head should neither be excessively flexed or
extended. A range of 30° to 60° extension is will be made during administration of Nasya
drops.
Administration of Sahchara taila Nasya 8 drops in each Nostril.( A.H.SU.20/10)
The palms and sole of the patient will be rubbed well with hands.
Patient will be asked to lie down in same position for 100 matrakala and spit out the
secretions reaching the mouth and not to swallow it.(A.H.SU.20/22)
Patient will be observed for Nasya Samyakadi Lakshana.)
(1) Medicine Name: SAHACHAR , Reference: CHARAK CHIKITSA , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: sushrut choikitsa 24/30-36, Procedure details: Patient will be lied down in prone position than local application of lukewarm Sahachara Taila will be done in Manyapradesha & skandha pradesh and mradu swenadiwill be given y nadi swedan)
(1) Medicine Name: sahachar tail, Reference: charak chikitsa 28, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Dhatukshayjanya Manyastambha explained in
Ayurveda texts. Patients will be selected irrespective of caste and religion, gender, habitat, occupation and Socio-economic status. |
|
| ExclusionCriteria |
| Details |
pregnant women and lactating mothers, known case of malignancy, chronic renal failure, MI, hypertension. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce in symptoms like Shool(pain),Stambha(stiffness). |
15 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Marked improvement in symptoms like Shool(pain) and Stambha(Stiffness) will be seen along with decrease in reading of VAS(visual analog scale) |
15 DAYS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/09/2025 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
A study will be conducted to evaluate the role of Nasya Karma and Abhyanga with Sahachara Taila in the management of Dhatukshayjanya Manyastambh . Symptomatic Degenerative cervical Spondylosis which is mainly Seen in elderly persons are now becoming common in Early & middle age persons also. Majority of Individuals over 40 years of age demonstrate Significant radiological evidence & major percentage Develops symptoms 60-70% of women and 85% of Men show changes of cervical spondylosis The internationally incidence of cervical Spondylosis is 2.5 cases per 1000 population In India shows an incidence of 3.5 cases per 1000 Population. 70% of general population is affected with Neck pain during their life. A CLINICAL COMPARITIVE STUDY OF EFFICACY OF SAHACHAR TAIl NASYA ALONG WITH ABHYANGA AND SAHACHAR TAIL NASYA IN THE MANAGEMENT OF MANYASTAMBHA W.S.R TO DEGENERATIVE CERVICAL SPONDYLOSIS. in this study researcher will prepare sahachara tail as per classical reference. objective of the study will be to assess the reduction in cardinal signs of manyastambha i.e shool, stambha. to assess the reduction in score before and after treatment in the following criteria stambh, shool, exclusion and inclusion criteria are taken. |