HIV InfectionsPhase 1/2NCT00276991
Traditional CAM Therapy in the Treatment of HIV/AIDS
A Phase 1/2 study testing "Kallunk oxide (Immunotherapy) " in people with HIV Infections, run by Traditional Alternative Medicine Research, India at 1 site in India.
Trial summary
This research work is important for the cure/control of HIV infection. The objectives of a treatment case on HIV patient is essentially to bring down the viral load closer to undetectable level. Read more about this study
- Who is it for?
- Ages 8 to 65 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
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2007to Oct 2009
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older 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 21 years of age
- Interest to use of study drugs
- Follow at a participating clinical site and
- Children of any age (greater than 8 years old)
Who cannot join
- Medical side effects
- Pregnant or breast feedings
- History of significant cardiac abnormalities or dysfunction
- Anti Retro viral Treatment ART used patients
- Received certain drugs or treatments
- Unable to followed at a participating clinical center
Show all 12Show fewer
- Children less than 8 years old
- 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
1 site in 1 country.
India1 site
Project Site Office, Hospital of Integrated Research Site HIRS(New), Ahammed Nagar, Mathura Nagar, Bhingar- PO
Mumbai, 414002
About this study
Official title: Modest Phase 1 and Phase II 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 objectives of a treatment case on HIV patient is essentially to bring down the viral load closer to undetectable level. The studies are depend on the potential influence of 'Kallunk Oxide' on the CD4+ T cells and the effectiveness on surface of HIV-1. The basic study is to break surface protein and directly inhibit a protein's increased functions, not only in the CD4+T cell but also CD3 and CD8+ T cells, by appropriate antidote.
The 'Yogaprabhava', the drug's effectiveness, and progressive immunity with diet and lifestyle can be more easily studied.
Read the detailed description
This research was individual investigator initiated meritorious project to identify potential roles for the safe and effective use of Complementary and Alternative Medicine CAM in the treatment of HIV infection.
This modest Phase-I and phase II clinical trials were intervention Studies. In the case of HIV infections, these studies were formulated each 20 random numbered batch. The Principal Investigator (PI) selects the informed consented patients and the recruited study was adhered by Helsinki Declaration.
Selection of subjects: HIV patients with CD3, CD4, and CD8 + T cell counts >450 cu/mm^3 were enrolled in Wing No: 1 group. HIV patients with CD+ T cell counts >450 cu/mm^3 were recruited for basic Arm study. The selected Arm - 1 of this research, the specific and potential milestone on baseline CD+T cell counts >450 cu/mm^3 was determined from the outcomes of previously conducted Observational Phase-1 study data.
The statistical evaluation laboratory on parameters in exists group was measured through Immune Cells Count Assay. The prolonged viral suppression and reversal of HIV seropositivity were the ultimate research outcomes and this study was evaluated the safety and efficacy of this drug. Absolute assays of Viral Load, Lymphocyte Enumeration, Western Blot blood test and convinced mean values and reference range methods were adopted for laboratory study.
The drug was administered as optimal doses 200 mg and 500 mg to study subjects, respectively, between 8 and 17 years old children and 18 and 65 years old Men and Women as anticipated 500 Female and 500 Male participants. The ELISA/P-24 test was used to confirm HIV-seropositivity.
The patients safe and effective optimum dose was the primary out come measure and the Viral Load assay and Immune Cells Count assay were the secondary outcome measure.
The randomized numbers were arranged with single patient's clinical records. Patient's body weight, CD4 T cells count, skin thickness, body measurements, blood pressure, temperature, pulse rates, anti body count, and other hematological examinations were investigated before and after the treatment period.
The well-designed research team minds the symptoms such as nausea, fatigue,weight loss, sweating, shortness of breath, joint pain etc and the Side effects of this treatment, if any, could be carefully noted. On entry and at the end of this study, the biochemical investigations such as urine examination, serum lipoprotein and cholesterol were individually noted.
Patient's temperature, digestion complaints, or chill, etc could treated by medicine and restricted diets without using mutton soup, milk, and cow ghee. The study was reduced patient's stress as well as depression and also managed the productivity, emotional well being, immunity and quality of life by the practice of this treatment.
The study was handled a transparent privacy environment to recruit HIV-infected people in India.
Dosage:
HIV patients were administered with once daily dose of sample size product, 500 mg for adults and 200 mg for children (up to 8 years old), as one course.
Controlled Nourished diet:
All patients were adhered with nourished diet protocol. The controlled diets were milk (only 1/2 cup), rice and wheat food products, cow ghee, green gram, mutton soup, and prepared black pepper added vegetable foods.
Restriction:
HIV-Patients were not used salts, other oils, mustard, and tamarind fish items within 10 days of this medication use.
Drug Administration:
HIV- patients were used one drug "Kallunk oxide (Immunotherapy)" as calcined/or oxidized molecules. The powder form sample size medicine was put into 1/2 cup hotter water (an adjuvant).
Precaution:
No precautions be needed. Patients were not used 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 was assigned only one Arm >450 cu/mm^3 of baseline CD + T cells. HIV type-1 subjects were received 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 0.100 mg and 0.200 mg "Kallunk oxide" molecules with 199.900 mg, and 499.800 mg "Antidote"( This antidote was used as a carrier of "Kallunk oxide" molecules), respectively, for children and adults. Dosage: 200 mg for children and 500 mg for adults. This powder form sample size product was administered once daily dose on 5 days treatment. The Botanical name of the antidote is "Piper Longum".
| Study group | Role | What they receive |
|---|---|---|
| "Kallunk oxide (Immunotherapy)" | Other | The participants were 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.
SafeDose,
Measured: Six months follow up
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 in Phase - II study
Prolonged Viral Suppression
Measured: Six Month's Follow up study( In Phase-II Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startNov 2007
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Lack of funding prevented the recruitment of 1000 HIV Patients all over India
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT00276991
- Sponsor's protocol ID
- TAM10
- Status last verified
- Nov 2015
- First submitted
- 12 Jan 2006
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modest Phase 1 and Phase II Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS
- ClinicalTrials.gov ID
- NCT00276991
- Acronym / sponsor ID
- TAM10
- Conditions
- HIV Infections
- Keywords
- Prolonged Viral Suppression, HIV Infections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding prevented the recruitment of 1000 HIV Patients all over India
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Traditional Alternative Medicine Research, IndiaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 13 Jan 2006 (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 objectives of a treatment case on HIV patient is essentially to bring down the viral load closer to undetectable level. The studies are depend on the potential influence of 'Kallunk Oxide' on the CD4+ T cells and the effectiveness on surface of HIV-1. The basic study is to break surface protein and directly inhibit a protein's increased functions, not only in the CD4+T cell but also CD3 and CD8+ T cells, by appropriate antidote.
The 'Yogaprabhava', the drug's effectiveness, and progressive immunity with diet and lifestyle can be more easily studied.
Detailed description
This research was individual investigator initiated meritorious project to identify potential roles for the safe and effective use of Complementary and Alternative Medicine CAM in the treatment of HIV infection.
This modest Phase-I and phase II clinical trials were intervention Studies. In the case of HIV infections, these studies were formulated each 20 random numbered batch. The Principal Investigator (PI) selects the informed consented patients and the recruited study was adhered by Helsinki Declaration.
Selection of subjects: HIV patients with CD3, CD4, and CD8 + T cell counts >450 cu/mm^3 were enrolled in Wing No: 1 group. HIV patients with CD+ T cell counts >450 cu/mm^3 were recruited for basic Arm study. The selected Arm - 1 of this research, the specific and potential milestone on baseline CD+T cell counts >450 cu/mm^3 was determined from the outcomes of previously conducted Observational Phase-1 study data.
The statistical evaluation laboratory on parameters in exists group was measured through Immune Cells Count Assay. The prolonged viral suppression and reversal of HIV seropositivity were the ultimate research outcomes and this study was evaluated the safety and efficacy of this drug. Absolute assays of Viral Load, Lymphocyte Enumeration, Western Blot blood test and convinced mean values and reference range methods were adopted for laboratory study.
The drug was administered as optimal doses 200 mg and 500 mg to study subjects, respectively, between 8 and 17 years old children and 18 and 65 years old Men and Women as anticipated 500 Female and 500 Male participants. The ELISA/P-24 test was used to confirm HIV-seropositivity.
The patients safe and effective optimum dose was the primary out come measure and the Viral Load assay and Immune Cells Count assay were the secondary outcome measure.
The randomized numbers were arranged with single patient's clinical records. Patient's body weight, CD4 T cells count, skin thickness, body measurements, blood pressure, temperature, pulse rates, anti body count, and other hematological examinations were investigated before and after the treatment period.
The well-designed research team minds the symptoms such as nausea, fatigue,weight loss, sweating, shortness of breath, joint pain etc and the Side effects of this treatment, if any, could be carefully noted. On entry and at the end of this study, the biochemical investigations such as urine examination, serum lipoprotein and cholesterol were individually noted.
Patient's temperature, digestion complaints, or chill, etc could treated by medicine and restricted diets without using mutton soup, milk, and cow ghee. The study was reduced patient's stress as well as depression and also managed the productivity, emotional well being, immunity and quality of life by the practice of this treatment.
The study was handled a transparent privacy environment to recruit HIV-infected people in India.
Dosage:
HIV patients were administered with once daily dose of sample size product, 500 mg for adults and 200 mg for children (up to 8 years old), as one course.
Controlled Nourished diet:
All patients were adhered with nourished diet protocol. The controlled diets were milk (only 1/2 cup), rice and wheat food products, cow ghee, green gram, mutton soup, and prepared black pepper added vegetable foods.
Restriction:
HIV-Patients were not used salts, other oils, mustard, and tamarind fish items within 10 days of this medication use.
Drug Administration:
HIV- patients were used one drug "Kallunk oxide (Immunotherapy)" as calcined/or oxidized molecules. The powder form sample size medicine was put into 1/2 cup hotter water (an adjuvant).
Precaution:
No precautions be needed. Patients were not used 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
| Arm | Type | Receives |
|---|---|---|
| "Kallunk oxide (Immunotherapy)" | Other | Drug: "Kallunk oxide (Immunotherapy) "The participants were received a daily regimen of "Kallunk oxide(Immunotherapy)" . |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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 21 years of age
Key exclusion criteria (12 listed)
- Medical side effects
- Pregnant or breast feedings
- History of significant cardiac abnormalities or dysfunction
- Anti Retro viral Treatment ART used patients
- Received certain drugs or treatments
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 was assigned only one Arm >450 cu/mm^3 of baseline CD + T cells. HIV type-1 subjects were received 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 0.100 mg and 0.200 mg "Kallunk oxide" molecules with 199.900 mg, and 499.800 mg "Antidote"( This antidote was used as a carrier of "Kallunk oxide" molecules), respectively, for children and adults. Dosage: 200 mg for children and 500 mg for adults. This powder form sample size product was administered once daily dose on 5 days treatment. The Botanical name of the antidote is "Piper Longum". | Drug | "Kallunk oxide (Immunotherapy)" |
Primary outcome
SafeDose,
Time frame: Six months follow up
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 in Phase - II study
Prolonged Viral Suppression
Time frame: Six Month's Follow up study( In Phase-II Study)
Results and safety
The study was stopped early (reason given: Lack of funding prevented the recruitment of 1000 HIV Patients all over India). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing "Kallunk oxide (Immunotherapy) " in people with HIV Infections, run by Traditional Alternative Medicine Research, India at 1 site 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 12 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: stopped early, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Lack of funding prevented the recruitment of 1000 HIV Patients all over India). Results are not available in the source record.
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?
SafeDose, (time frame: Six months follow up). 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 4 Nov 2015.