HIV InfectionsPhase 3NCT01349062
Traditional Complementary and Alternative Medicine (CAM) Therapy in the Treatment of HIV/AIDS
A Phase 3 study testing "Kallunk oxide (Immunotherapy) " in people with HIV Infections, run by Traditional Alternative Medicine Research, India at 3 sites in India.
Trial summary
This research work is important for the cure/control of HIV infection. The study is intended to confirm the efficacy of "Kallunk Oxide (Immunotherapy)" molecules in the Treatment of HIV infection. Read more about this study
- Who is it for?
- Ages 8 to 45 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- "Kallunk oxide (Immunotherapy) "
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 3 sitesIndia
- Study dates
- 27 Feb 2012to 27 Feb 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of HIV/AIDS
- Able to swallow tablets or powder form medicine
- Able to eat nutritional foods
- HIV infected patients
- Signed consent of parent or guardian for patients under 18 years of age
- Interest to use of study drugs
- Follow at a participating clinical site and
- Children greater than 8 years old.
Who cannot join
- Medical side effects
- Pregnant or breast feedings
- History of significant cardiac abnormalities or dysfunction
- Received certain drugs (Steroid) or treatments
- Unable to followed at a participating clinical center
- Children less than 8 years old
Show all 11Show fewer
- Any serious conditions (severe chronic stage AIDS cases) at study entry that may affect the results of the study.
- Allergy to any of the study drugs or their formulations
- Tobacco using patients
- Alcohol using patients and
- Drug addicting patients.
Trial locations and contacts
3 sites in 1 country.
India3 sites
Project Site Office, Hospital of Integrated Research Site HIRS(New), Karoor, Ambalapuzha-PO, Alleppey-District, Kerala, India 688561
Alappuzha, 688561
Project Site Office, Hospital of Integrated Research Site HIRS(New), Ahammed Nagar, Mathura Nagar, Bhingar- PO
Mumbai, 414002
Project Site Office, Near Sivan Kovil, Nallepily, Hospital of Integrated Research Site HIRS [new])
Palakkad, Kerala, 678553
About this study
Official title: Phase III Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS
This research work is important for the cure/control of HIV infection. The study is intended to confirm the efficacy of "Kallunk Oxide (Immunotherapy)" molecules in the Treatment of HIV infection. The study will investigate the T- Lymphocytes (immune) response to HIV in order to boost the body's natural immune ability against infection. The basic study is directly inhibit a protein's increased functions, not only in the CD4+T cell but also CD3+ and CD8+ T cells and the CD45+. cells.
The 'Yogaprabhava', the drug's effectiveness, and progressive immunity with diet and lifestyle can be more easily studied.
Read the detailed description
This research study is an individual investigator initiated meritorious project to confirm the efficacy of "Kallunk Oxide (Immunotherapy)" in the treatment of HIV- infection.The Previous clinical studies are showing that the T- Lymphocytes responses to "Kallunk Oxide (Immunotherapy)" is effective in the treatment of HIV- infection.
This randomized intervention study to confirm the efficacy of booster dose Kallunk Oxide molecules 5 mg to all participants,especially, greater than 8 years old children (Adolescence and Adults) , men and women. The Principal Investigator will be selected the informed consented patients to recruit for this trial. This study will be adhered by "Helsinki Declaration".
The patient's assays of Lymphocyte enumeration is the primary end point. Immune output of this drug and it's progressive immunity against HIV cure will follow- up. The study will be investigated the T- Lymphocytes (immune) response to HIV. The impact of the CD3+, CD4+,CD8 T cells and CD45+ response to "Kallunk Oxide (Immunotherapy)" will be studied.
Patient's body weight, CD4+ T cells and other hematological status will be investigated before and after the treatment period.
The research team is also mindful the symptoms such as nausea, fatigue and weight loss, sweating, shortness of breath, joint pain, etc. will individually being noted.
During this treatment period, in case, any of the patients have temperature, digestion complaint or chill, etc. may vary. Only in this circumstance,the patients not advised to use the controlled diet protocol or use of mutton soup, cow milk and cow ghee.
Privacy and Confidentiality:
The study must be handled a transparent privacy environment to recruit HIV-infected people all over India and the data will be confidentially protected with genuine written informed consent.
Dosage:
5 mg "Kallunk Oxide (Immunotherapy)" molecules with the antidote 1995 mg "Long Pepper"(Botanical name- Piper longum) for > 8 to < 45 years old children and adults from both genders.The study will also be evaluated the effectiveness of booster dose Kallunk Oxide (5 mg) and "Long Pepper" (1995 mg) in ART drug ( one tablet contains Zidovudine, lamivudine, and nevirapine ) using adults (<45) and adolescence (the ages12 to 18 years female and 14 to 18 years old male) to access serum negative status of HIV in CD+ T cell number <350 cu/mm^3 of ART using HIV-patients..
Favorable results on integrative intervention approach is point out that before using "Kallunk Oxide (Immunotherapy)' with ART is need nearly a six hour time frame. More meaningfully, it is stated that the HIV/AIDS patient may use ART at the evening time to avoid possible side effects as joint pain and fatigue (which are seldom cases).
The booster dose regimen of this therapy is administered as once daily dose for 10 days adherence for six months ART drug (Not Kallunk Oxide Therapy) tolerance. If the virus is not suppressed completely, drug resistance can develop. So, through this study the serum negative status of HIV from baseline to 24 weeks will be followed-up.
Dosage: powder form sample size product 2 gm (Kallunk Oxide + Antidote) for children and adults as once daily dose and is recommended to 7 days daily regimen for monthly use as mentioned baseline and six (6) months time frame.
Controlled Nourished diet:
Patients will be controlled by nourished diet protocol. Eat wheat products, rice food products, cow milk (only ½ cup), cow ghee, green gram,banana, mutton soup,sweet fruits as apple (only sweet), orange and prepared black pepper added vegetable foods.
Restriction:
Salts, other oils, mustard,Pumpkin,lemon juice, and tamarind fish items are not use within 10 days of medication.
Drug Administration:
In this study, patients can use the capsule/powder form medicine with 1/2 cup hotter water. HIV- patients be used one drug "Kallunk oxide (Immunotherapy)" as calcined/or oxidized molecules.
Precaution:
No precaution is needed. The patients can avoid sediments at the bottom of the cup.
- Conditions
- HIV Infections
- Being tested
- "Kallunk oxide (Immunotherapy) "
- Keywords
- Prolonged Viral Suppression, HIV Infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Kallunk oxide (Immunotherapy) "Drug
Also called 'Kallide'
The study is assigned Arm 1 above 450 cu/mm^3 baseline CD + T cells. HIV type-1 subjects will receive one drug, a daily regimen of "Kallunk oxide(Immunotherapy) + Long Pepper", that is a combination of a traditional alternative medicine (Complementary and Alternative Medicine CAM) as "Kallunk oxide" and appropriate drug carrier antidote. The drug assigns to 5 mg "Kallunk oxide" molecules with1995 mg "Antidote"( This antidote was used as a carrier of "Kallunk oxide" molecules), respectively, for children and adults. Dosage: 2000 mg for children and adults. This powder form sample size product will be administered once daily dose on 7 days treatment. The Botanical name of the antidote is "Piper Longum".
| Study group | Role | What they receive |
|---|---|---|
| "Kallunk oxide (Immunotherapy)" | Other | The participants will be received a daily regimen of "Kallunk oxide(Immunotherapy)" . Receives: Drug: "Kallunk oxide (Immunotherapy) " |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Number of participants with adverse events for efficacy by mentioned time frame will be assessed.
Measured: Number of Participants with Adverse Events by weeks 24
Secondary outcomes (3)
Viral Load Assay
Measured: Three months follow up
Absolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells)
Measured: Three months follow up study
Prolonged Viral Suppression
Measured: Six Month's Follow up study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study start27 Feb 2012
- Primary completion27 Feb 2017
- Study completion27 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Traditional Alternative Medicine Research, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMAKRISHNAN MADHUSOODANAN, Traditional Alternative Medicine Research, India
- Investigators
- Ramakrishnan Madhusoodanan, PHD, Principal investigator, Traditional Alternative Medicine Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349062
- Sponsor's protocol ID
- 00276991
- Status last verified
- Mar 2017
- First submitted
- 3 May 2011
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS
- ClinicalTrials.gov ID
- NCT01349062
- Acronym / sponsor ID
- 00276991
- Conditions
- HIV Infections
- Keywords
- Prolonged Viral Suppression, HIV Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Traditional Alternative Medicine Research, IndiaUniversity, hospital or other
- Study start
- 27 Feb 2012 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 6 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research work is important for the cure/control of HIV infection. The study is intended to confirm the efficacy of "Kallunk Oxide (Immunotherapy)" molecules in the Treatment of HIV infection. The study will investigate the T- Lymphocytes (immune) response to HIV in order to boost the body's natural immune ability against infection. The basic study is directly inhibit a protein's increased functions, not only in the CD4+T cell but also CD3+ and CD8+ T cells and the CD45+. cells.
The 'Yogaprabhava', the drug's effectiveness, and progressive immunity with diet and lifestyle can be more easily studied.
Detailed description
This research study is an individual investigator initiated meritorious project to confirm the efficacy of "Kallunk Oxide (Immunotherapy)" in the treatment of HIV- infection.The Previous clinical studies are showing that the T- Lymphocytes responses to "Kallunk Oxide (Immunotherapy)" is effective in the treatment of HIV- infection.
This randomized intervention study to confirm the efficacy of booster dose Kallunk Oxide molecules 5 mg to all participants,especially, greater than 8 years old children (Adolescence and Adults) , men and women. The Principal Investigator will be selected the informed consented patients to recruit for this trial. This study will be adhered by "Helsinki Declaration".
The patient's assays of Lymphocyte enumeration is the primary end point. Immune output of this drug and it's progressive immunity against HIV cure will follow- up. The study will be investigated the T- Lymphocytes (immune) response to HIV. The impact of the CD3+, CD4+,CD8 T cells and CD45+ response to "Kallunk Oxide (Immunotherapy)" will be studied.
Patient's body weight, CD4+ T cells and other hematological status will be investigated before and after the treatment period.
The research team is also mindful the symptoms such as nausea, fatigue and weight loss, sweating, shortness of breath, joint pain, etc. will individually being noted.
During this treatment period, in case, any of the patients have temperature, digestion complaint or chill, etc. may vary. Only in this circumstance,the patients not advised to use the controlled diet protocol or use of mutton soup, cow milk and cow ghee.
Privacy and Confidentiality:
The study must be handled a transparent privacy environment to recruit HIV-infected people all over India and the data will be confidentially protected with genuine written informed consent.
Dosage:
5 mg "Kallunk Oxide (Immunotherapy)" molecules with the antidote 1995 mg "Long Pepper"(Botanical name- Piper longum) for > 8 to < 45 years old children and adults from both genders.The study will also be evaluated the effectiveness of booster dose Kallunk Oxide (5 mg) and "Long Pepper" (1995 mg) in ART drug ( one tablet contains Zidovudine, lamivudine, and nevirapine ) using adults (<45) and adolescence (the ages12 to 18 years female and 14 to 18 years old male) to access serum negative status of HIV in CD+ T cell number <350 cu/mm^3 of ART using HIV-patients..
Favorable results on integrative intervention approach is point out that before using "Kallunk Oxide (Immunotherapy)' with ART is need nearly a six hour time frame. More meaningfully, it is stated that the HIV/AIDS patient may use ART at the evening time to avoid possible side effects as joint pain and fatigue (which are seldom cases).
The booster dose regimen of this therapy is administered as once daily dose for 10 days adherence for six months ART drug (Not Kallunk Oxide Therapy) tolerance. If the virus is not suppressed completely, drug resistance can develop. So, through this study the serum negative status of HIV from baseline to 24 weeks will be followed-up.
Dosage: powder form sample size product 2 gm (Kallunk Oxide + Antidote) for children and adults as once daily dose and is recommended to 7 days daily regimen for monthly use as mentioned baseline and six (6) months time frame.
Controlled Nourished diet:
Patients will be controlled by nourished diet protocol. Eat wheat products, rice food products, cow milk (only ½ cup), cow ghee, green gram,banana, mutton soup,sweet fruits as apple (only sweet), orange and prepared black pepper added vegetable foods.
Restriction:
Salts, other oils, mustard,Pumpkin,lemon juice, and tamarind fish items are not use within 10 days of medication.
Drug Administration:
In this study, patients can use the capsule/powder form medicine with 1/2 cup hotter water. HIV- patients be used one drug "Kallunk oxide (Immunotherapy)" as calcined/or oxidized molecules.
Precaution:
No precaution is needed. The patients can avoid sediments at the bottom of the cup.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| "Kallunk oxide (Immunotherapy)" | Other | Drug: "Kallunk oxide (Immunotherapy) "The participants will be received a daily regimen of "Kallunk oxide(Immunotherapy)" . |
Who may qualify
- Ages
- 8 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of HIV/AIDS
- Able to swallow tablets or powder form medicine
- Able to eat nutritional foods
- HIV infected patients
- Signed consent of parent or guardian for patients under 18 years of age
Key exclusion criteria (11 listed)
- Medical side effects
- Pregnant or breast feedings
- History of significant cardiac abnormalities or dysfunction
- Received certain drugs (Steroid) or treatments
- Unable to followed at a participating clinical center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Kallunk oxide (Immunotherapy) "Also: 'Kallide'The study is assigned Arm 1 above 450 cu/mm^3 baseline CD + T cells. HIV type-1 subjects will receive one drug, a daily regimen of "Kallunk oxide(Immunotherapy) + Long Pepper", that is a combination of a traditional alternative medicine (Complementary and Alternative Medicine CAM) as "Kallunk oxide" and appropriate drug carrier antidote. The drug assigns to 5 mg "Kallunk oxide" molecules with1995 mg "Antidote"( This antidote was used as a carrier of "Kallunk oxide" molecules), respectively, for children and adults. Dosage: 2000 mg for children and adults. This powder form sample size product will be administered once daily dose on 7 days treatment. The Botanical name of the antidote is "Piper Longum". | Drug | "Kallunk oxide (Immunotherapy)" |
Primary outcome
Efficacy
Time frame: Number of Participants with Adverse Events by weeks 24
Number of participants with adverse events for efficacy by mentioned time frame will be assessed.
3 secondary outcomes
Viral Load Assay
Time frame: Three months follow up
Absolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells)
Time frame: Three months follow up study
Prolonged Viral Suppression
Time frame: Six Month's Follow up study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramakrishnan Madhusoodanan, PHD principal investigator
Traditional Alternative Medicine Research Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing "Kallunk oxide (Immunotherapy) " in people with HIV Infections, run by Traditional Alternative Medicine Research, India at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: Number of Participants with Adverse Events by weeks 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.