| CTRI Number |
CTRI/2022/05/042366 [Registered on: 04/05/2022] Trial Registered Prospectively |
| Last Modified On: |
29/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of a poly-herbal compound on immune status of healthy human subjects
|
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Evaluate the Immunomodulatory Profile of a Polyherbal Compound OC22 on Apparently Healthy Volunteers
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Shubham Garg |
| Designation |
Associate Professor |
| Affiliation |
GS Ayurveda Medical College and Hospital |
| Address |
Department of Dravyaguna
NH-24,Pilkhuwa, Hapur,
Ghaziabad
UTTAR PRADESH
245304
India |
| Phone |
9997772737 |
| Fax |
|
| Email |
vdshubhamgarg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankur Singhal |
| Designation |
Professor & Head |
| Affiliation |
GS Ayurveda Medical College and Hospital Hapur |
| Address |
Department of Kaya chikitsa,
NH-24,Pilkhuwa, Hapur,
Ghaziabad
UTTAR PRADESH
245305
India |
| Phone |
9760768689 |
| Fax |
|
| Email |
drankursinghal2015@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogita Bisht |
| Designation |
Associate Professor |
| Affiliation |
GS Ayurveda Medical College & Hospital |
| Address |
Department of Kaya chikitsa,
NH-24,Pilkhuwa, Hapur,
Ghaziabad
UTTAR PRADESH
245305
India |
| Phone |
9958288312 |
| Fax |
|
| Email |
yogitabishtmehra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ms Saatvik Enterprises |
| Address |
Dheeraj Gaur, Shop no. 226, 2nd floor, Mall- Saviour street, Commercial plot no. C-3, Crossing Republic, Dundahera, NH-24, Ghaziabad, U P.201016, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Vd Shubham Garg |
GS Ayurveda Medical College and Hospital |
Room no 7 Department of Kayachikitsa Hospital Block
Ghaziabad
UTTAR PRADESH |
9997772737
vdshubhamgarg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GS Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To see the immunomodulatory effects, clinical trial is being conducted on apparently healthy volunteers of both sexes, aged 20-40 years
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: OC22, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | No treatment | No treatment control group |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1-Apparently Healthy individuals aged 20-40 years of either sex.
2-Individuals giving consent for participation.
|
|
| ExclusionCriteria |
| Details |
1-Individuals with chronic co-morbid conditions which might have affected the immune status of the individual.
2-Pregnant or lactating mother
3-Person on any interventional drug like vitamin/mineral/hormonal supplements/protein supplements etc. or any other nutritional supplements
|
|
|
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 |
| Improvement in Immune status as evaluated by ISQ |
Baseline
3 months from Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Immunoglobulin (IgG, IgM) levels |
Baseline
3 months from Baseline
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/05/2022 |
| Date of Study Completion (India) |
16/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
Modification(s)
|
There are various types of Rasayana described in Ayurveda which impart strength to immune system in order to support the other bodily systems. Some of these Rasayana substances which are popular immunomodulators like Amalki, Ashwagandha, Tulsi etc. have been included in the study compound. It will be a prospective, randomized, longitudinal, double arm (treatment-control) study to evaluate the immunomodulatory effects of a polyherbal compound OC22, if any. The proposed study will be conducted on two groups i.e. one will be the treatment group and the other will be the no treatment control group. sIntervention ubjects will be administered with 6g powder of Poly-herbal compound with water, once daily i.e. empty stomach in morning for 3 months. Immune modulation will be assessed by Immune Status Questionnaire, IgG and IgM. Pre and post intervention results will be compared. |