| CTRI Number |
CTRI/2025/05/087551 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical Study comparing the effectiveness of Simhnad Guggulu and Panchamrita Lauha Guggulu with Amalakadi Choorna in Manyastabha treatment. |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the efficacy of Simhnad Guggulu And Panchamrita Lauha Guggulu along with Amalakadi Choornam in the management of Manyastambha |
| 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 Kuldeep |
| Designation |
Associate Professor, Department of Kayachikitsa, Shiva Ayurvedic College And Hospital P.O Chandpur, Distt. Bilaspur, Himachal Pradesh. |
| Affiliation |
Atal Medical and Research University Distt. Mandi, Himachal Pradesh |
| Address |
Opd Block, Room no 403, Kayachikitsa Opd, Shiva Ayurvedic College And Hospital P.O Chandpur, Distt. Bilaspur, Himachal Pradesh.
Pin 174004.
Bilaspur
HIMACHAL PRADESH
174004
India |
| Phone |
7018918260 |
| Fax |
|
| Email |
kdeep.thakur1990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Gourisankar |
| Designation |
Professor and Head Department of Kayachikitsa, Glocal College of Ayurvedic Medical Sciences and Research Centre Saharanpur,Uttar Pradesh. |
| Affiliation |
Glocal University,Delhi yamunotri Marg,state Highway 57,Mirzapur Pole, Saharanpur, U.P |
| Address |
Opd Block,Room no.1, Kayachikitsa opd, Glocal University,Delhi yamunotri Marg,state Highway 57,Mirzapur Pole, Saharanpur, U.P
Saharanpur
UTTAR PRADESH
247121
India |
| Phone |
9447308867 |
| Fax |
|
| Email |
drpgourisankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kuldeep |
| Designation |
Associate Professor, Department of Kayachikitsa,Shiva Ayurvedic College And Hospital P.O Chandpur, Distt. Bilaspur, Himachal Pradesh. |
| Affiliation |
Atal Medical and Research University Distt. Mandi,Himachal Pradesh. |
| Address |
Opd Block, Room No.403, Kayachikitsa opd, Shiva Ayurvedic College And Hospital P.O Chandpur, Distt. Bilaspur, Himachal Pradesh.
Pin 174004.
Bilaspur
HIMACHAL PRADESH
174004
India |
| Phone |
7018918260 |
| Fax |
|
| Email |
kdeep.thakur1990@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shiva Ayurvedic Medical College and Hospital P.O Chandpur Distt Bilaspur himachal Pradesh Pin 174004 |
|
|
Primary Sponsor
|
| Name |
Dr Kuldeep Associate Professor Department of Kayachikitsa |
| Address |
Shiva Ayurvedic Medical College And Hospital P.O Chandpur Distt Bilaspur, Himachal Pradesh |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 Kuldeep |
Shiva Ayurvedic Medical College and Hospital |
Room No 403,Shiva Ayurvedic Medical College and Hospital P.O Chandpur, Distt Bilaspur, Himachal Pradesh
Bilaspur
HIMACHAL PRADESH |
7018918260
kdeep.thakur1990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Glocal University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amalakadi Choornam, Reference: Sarangdhar Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -Ushnodaka), Additional Information: -(2) Medicine Name: Simhnad Guggulu, Reference: Bhaisajyaratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Ashtavargam Kashyam 30 ml with equal quantity of ushnodaka), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amalakadi Choornam, Reference: Sarangdhar Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: -(2) Medicine Name: Panchamrita Lauha Guggulu, Reference: Ras Tantra Sara Evum Siddha Prayoga Samgraha, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Ashtavargam Kashyam 30ml with equal quantity of ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects between the age group of 20 to 60 years.
2. The subjects with classical signs and symptoms of Manyasthamba .
3. Subjects of all genders, irrespective of religion and caste. |
|
| ExclusionCriteria |
| Details |
1. Patients below 20 and above 60 years of age.
2. Pregnant and lactating mother.
3. Subjects with other systemic disorders such as accelerated hypertension, uncontrolled diabetes, gastritis, acid peptic disorder, hypothyroidism that interfere in the line of treatment.
4. Subjects with congenital deformity, traumatic injuries, cervical stenosis & myelopathy, ankylosing spondylitis, infections of bones, and gross bony deformity.
5. Patient suffering from autoimmune joint disorders. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Ruk(Pain), Stambha(Stiffness) of Manyapradesha. |
95days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in pain Vas Score, Neck disability index score and Neck range of movement |
95 days |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2025 |
| 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="3"
Months="0"
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
|
The present study is an interventional, open label, parallel group trial which aims to evaluate and compare the efficacy of Simhanad Guggulu and Panchamrita lauha guggulu along with Amalakadi choornam in the management of manyastambha. One hundred and forty patient aged 20 - 60 years with classical features of mayastambha will be randomly categoriesd in two groups i.e 70 patients in each groups. In both groups for amapachana Amalakadi Choornam will be given for 5 days which is followed by simhanad Guggulu 500mg BD in Group A for 60 days. while in Group B after Amapachan Panchamrita lauha Guggulu 500mg BD for 60 days will be given.for both groups Ashtavargam Kashyam 30 ml is used as anupana for guggulu kalpas.After medication patient will observed for 30 days in both groups. So overall study duration becomes 95 days and followup will be done after 15 days . |