| CTRI Number |
CTRI/2024/07/071260 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Chavyadi Churna with and without Lekhana Basti in the treatment of Obesity |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Chavyadi Churna With And Without Lekhana Basti In The Management Of Sthaulya (Obesity) |
| 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 Parul Saini |
| Designation |
PG Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University |
| Address |
Department of Kaya Chikitsa,
Adarsh Institutional Area, Babu Vijendra Marg, Gangoh, Distt. Saharanpur, (U.P.) India
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
7719612805 |
| Fax |
|
| Email |
psaini1525@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parul Saini |
| Designation |
PG Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University |
| Address |
Department of Kaya Chikitsa,
Adarsh Institutional Area, Babu Vijendra Marg, Gangoh, Distt. Saharanpur, (U.P.) India
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
7719612805 |
| Fax |
|
| Email |
psaini1525@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bandana Dhall |
| Designation |
Professor |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University |
| Address |
Department of Kaya Chikitsa, Adarsh Institutional Area, Babu Vijendra Marg, Gangoh, Distt. Saharanpur, (U.P.) India
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9348061460 |
| Fax |
|
| Email |
bandanadhall1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University, Adarsh Institutional Area, Babu Vijendra Marg, Gangoh, Distt Saharanpur, 247341(U.P.) India |
|
|
Primary Sponsor
|
| Name |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre Shobhit University |
| Address |
Adarsh Institutional Area, Babu Vijendra Marg, Gangoh, Distt. Saharanpur, 247341 (U.P.) India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Parul Saini |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University |
Department of Kaya Chikitsa ,Adarsh Institutional Area, Babu Vijendra Marg, Gangoh, Distt. Saharanpur, 247341 (U.P.) India
Saharanpur
UTTAR PRADESH |
7719612805
psaini1525@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chavyadi Churna, Reference: Vaidya Chintamani vol 2 -chapter 24/9, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu and Saktu), Additional Information: | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushrutha Samhita Chikitsa Sthana Chapter 38/82, Procedure details: Basti will be given in left lateral position by Basti yantra in Panchkarma department before meal in morning hours. Lekhana Basti will be given in Kaal yoga manner for 15 days i.e. 1 Anuvasan Basti at the beginning and 3 Anuvasan Basti at the end with 6 Anuvasan Basti and 5 Niruha Basti on alternate days. Anuvasana Basti of Tila Taila will be given in the dose of 124ml.)
(1) Medicine Name: Chavyadi Churna, Reference: Vaidya Chintamani vol 2 - chapter 24/9, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 45 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to sign the consent form.
2.Patients having clinical features of obesity.
3.Patients between the age group of 18-50 years of either sex.
4.Body mass index (BMI) from 30-39.9 i.e. Class 1 and class 2 obesity.
5.Waist Circumference greater than 102 cm (40 in) in men and greater than 88 cm (35in) in women.
|
|
| ExclusionCriteria |
| Details |
1.Patients in the age group of less than 18 years and more than 50 years will not be included for the present study.
2.Patients not willing for clinical trial.
3.Obese patients suffering from obesity due to hormonal imbalance, hypothyroidism, cardiovascular diseases, hemiplegia, associated with severe hypertension(160/110 and higher), liver and kidney disease, uncontrolled diabetes mellitus (HbA1c 6.5% and higher), pregnant and lactating mothers. and from other such diseases in which the patient cannot do his routine physical activities will be excluded.
4.Very obese patients having BMI 40 or more than 40 will be excluded from the present study.
Patient under another clinical trial.
5.Patient on steroids therapy and oral contraceptive therapy.
6.Patients of Ajeerna, Ati Snigdha, Peeta Sneha, Utklishta Dosha, Alpa Agni. Yana Klanta, Ati
Durbala, Kshudaarta, Trishnarta, Shramaarta, Ati Krusha, Bhuktabhakta, Peeta Udaka, Vamita. Virikta, Kurta Nasya Karma, Kruddha, Bheeta, Kasa Prasakia, Hikka Prasakta, Dakodara, Aadhmana, Visuchika, Ama Dosha. Kushta, Arsha, Pandu, Unmada, Shopha.
7.Patients allergic to the contents of Basti |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in sign and symptoms of staulya |
Reduction in sign and symptoms of staulya |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To observe adevrse effects if any.
2. Cost effective treatment |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 3 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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)
|
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 volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. The clinical research format will be prepared and validated. Prior to the study, approval will be taken from IEC, KSVAMC & RC, SU GANGOH, SAHARANPUR and CTRI registration will be done after selection, each participant will be tested individually and selected according to the selection criteria. They are divided into two groups a trial is a parallel group, randomized, open label trial. It will include 45v days treatment period and an every 15th day follow up period |